Category: Medicine, Drugs & Devices

JunkScience.com right again: No prostate test for healthy men

“Healthy men should no longer receive a P.S.A. blood test to screen for prostate cancer because the test does not save lives over all and often leads to more tests and treatments that needlessly cause pain, impotence and incontinence in many, a key government health panel has decided,” reports the New York Times. But JunkScience.com was all over this more than 13 years ago. Continue reading JunkScience.com right again: No prostate test for healthy men

Palmetto extract: Snake oil for the prostate

The most widely used over-the-counter supplement for prostate health is no more effective than a placebo in treating men’s lower urinary tract symptoms, report researchers in the Journal of the American Medical Association. Continue reading Palmetto extract: Snake oil for the prostate

Name that drug

While we have a healthy skepticism toward the pharmaceutical industry, former Obama adviser Ezekiel Emanuel’s attack in the New York Times on Big Pharma for not selling cancer drugs because they can’t make any money is long on accusation but short on facts: Continue reading Name that drug

Can't kill snake oil with a stick: Medicare to keep paying for Avastin

Medicare and Medicaid will continue to pay for Avastin prescribed for breast cancer even though the drug offers no meaningful benefits — certainly none worth $88,000 per patient per year to taxpayers. It will be hard to control the Medicare entitlement if snake oil is to be made available on demand.

Cholesterol Drug Scare Shenanigans

By Steven Milloy
September 04, 2008, FoxNews.com

Why is the editor of the New England Journal of Medicine encouraging a cancer scare over the cholesterol-lowering drug Vytorin? Is he overcompensating for past bad behavior?

Prescribed for millions of patients, Vytorin is a single pill that combines the cholesterol-lowering medicines Zocor and Zetia. Its popularity declined in early 2008 after several studies questioned whether Vytorin produced any health benefit and a panel of cardiologists recommended that the drug be used only as a last resort.

Then, in July, a Norwegian researcher reported that, in a clinical trial known as SEAS, 102 patients taking Vytorin developed cancer, compared with 67 patients taking a placebo — a statistically significant result indicating that chance could be ruled out with some degree of confidence as the cause.

Drug companies Merck and Schering-Plough, the makers of Zocor and Zetia, respectively, subsequently commissioned famed epidemiologist Richard Peto of Oxford University to evaluate the SEAS results. Those findings were published this week on the Web site of the New England Journal of Medicine.

Based on his review of SEAS and two other ongoing Vytorin trials (called SHARP and IMPROVE-IT), Peto concluded that the trials provided no credible link between Vytorin and cancer risk, although follow-up would be needed to make a more reliable determination.

Peto based his conclusion on the fact that in the SEAS trial, there were no statistically significant increases in any specific type of cancer; the statistically significant result occurred only by adding all cancers together. Moreover, for the three specific cancers with reported risks closest to attaining statistical significance in the SEAS trial — skin, stomach and prostate — the results were precisely the opposite of what occurred in the SHARP and IMPROVE-IT trials. That is, in those trials, placebo patients had higher rates of cancer at those sites than did Vytorin users.

Additionally, Peto found no increase in risk of cancer over time in the three trials — generally, cancer risk increases with increasing exposure to a cancer-causing substance. This observation, he acknowledged, will also require more follow-up, since the patients in the trials have been followed for only a few years.

Although more Vytorin users than placebo patients died from cancer in all three trials, the result was only statistically significant in the SEAS trial. But Peto dismissed the SEAS result, since it was what had generated all the controversy in the first place and so couldn’t be used to verify the validity of a link between Vytorin and cancer. More telling than overall cancer deaths, however, was the lack of a statistically significant excess number of deaths from any specific type of cancer.

Though the available data don’t absolutely prove that Vytorin doesn’t increase cancer risk, there seems to be no good reason to think that it does — unless you’re the editor of the New England Journal of Medicine.

In an editorial accompanying the Peto analysis, editor Jeffrey Drazen wrote that, “Although the Oxford group may ultimately prove to be correct, it is appropriate to raise a note of caution.” Without providing any back-up scientific data, Drazen then speculated that since Vytorin works by interfering with the gastrointestinal absorption of cholesterol, it might also interfere with the absorption of other unnamed molecular entities that “could conceivably affect the growth of cancer cells.” Drazen also was unwilling to cede that higher cancer death rate of Zetia patients was simply due to chance “until further data are in.”

But the main reason that Drazen is simply wrong about keeping the Vytorin cancer scare on life support is that there’s no evidence whatsoever that the drug is associated with any specific form of cancer at any specific site.

For example, excessive smoking is associated with lung cancer, and occupational asbestos exposure is associated with mesothelioma. But given a specific route of exposure, no potential carcinogen is known to cause cancer at multiple sites on a random or haphazard basis. Aggregating different cancers into a catch-all “all cancer” category simply lacks demonstrable biological plausibility.

Drazen’s insistence on waiting for more data on cancer deaths is similarly nonsensical. Vytorin would first need to be associated with an increased risk of a death from a specific form of cancer — a notion clearly contradicted by the data so far.

None of this should be controversial or new to Drazen. So what’s up with him?

Prior to becoming editor of the New England Journal of Medicine, Drazen had close ties with many drug companies — and once got into trouble because of them.

In March 1999, the Food and Drug Administration found that Drazen made “false and misleading” statements about the safety and efficacy of the asthma drug levalbuterol made by Sepracor — a drug company that hired Drazen to review two studies on the drug and then to comment to a company interviewer. Needless to say, given this past, his NEJM appointment was somewhat controversial.

So since becoming editor, Drazen has seemingly gone out of his way to turn against the hand that once fed him. In a May 2005 Wall Street Journal article entitled, “Medical Editor Turns Activist On Drug Trials,” former NEJM editor Marcia Angell said that, “[Drazen’s] been converted. Through painful experience, Jeff is learning what these companies are about. He sees the ugly side that he hadn’t seen before — the bias that company-sponsored research contains, the suppression of results that they don’t like, the spin of unfavorable results.” Dr. Angell would apparently have us believe that Sepracor forced or tricked Drazen into saying “false and misleading” things about their drug.

So now it seems that instead of pro-drug company bias and spin, Drazen now leans toward anti-drug company bias and spin. Imagine if Drazen were just to stick to science in the first place. He wouldn’t have to worry about shifting alliances to atone for his mistakes.

Steven Milloy publishes JunkScience.com and DemandDebate.com. He is a junk science expert, and advocate of free enterprise and an adjunct scholar at the Competitive Enterprise Institute.

FDA May Make Breathing Difficult for Asthmatics

By Steven Milloy
January 26, 2006, FoxNews.com

The government may tell asthmatics to “take a hit” for the environment. But that “hit” won’t be from their inhalers, which might be taken away.

A Food and Drug Administration advisory panel voted this week to recommend removing the “essential use” status that permits inexpensive, nonprescription asthma inhalers, like Primatene Mist, to remain on sale.

Powered by chlorofluorcarbon (CFC) propellants, the inhalers shoot epinephrine into the lungs of asthmatics, allowing them to breathe during potentially life-threatening asthma attacks. But environmentalists labeled CFCs a threat to the ozone layer in the 1980s, leading to an international phase-out of CFCs under the 1987 Montreal Protocol.

Nonprescription inhalers – and millions of asthmatics – have so far survived the Montreal Protocol because CFC use in inhalers is deemed to be “essential” and, therefore, exempt from the ban. Wyeth Consumer Healthcare estimates that 3 million Americans use its Primatene for mild or intermittent asthma and about 700,000 use Primatene alone because they can’t get prescriptions or lack health insurance, according to the Seattle Times (Jan. 25). Wyeth says that substitute non-CFC inhalers won’t be ready until 2009 or 2010 – and probably at a much higher cost.

But the FDA panel was apparently swayed by arguments that CFC-inhaler use threatens the ozone layer and public health. The hypothesis-of-hysteria is that CFCs thin the stratospheric ozone layer which, in turn, allows more solar ultraviolet (UV) radiation to reach the Earth’s surface which, in turn, increases the risk of skin cancer, cataracts and other health problems.
But asthmatics should not have to gasp for air because of this guesswork.

First, accepting for argument’s sake that ozone depletion alarmism is justified, only a trivial amount of CFCs would be released into the atmosphere due to inhaler use. No detectable damage to the ozone layer would likely result.

Global CFC production peaked pre-ban at over 1 million metric tons. But in 1999, for example, the U.S. requested an “essential use” exemption of only about 4,000 metric tons for inhalers – hardly a return to the old days when CFCs were used in a wide range of consumer and industrial products.

Back to the real world, however, the ozone depletion hypothesis has a great big hole of its own.

No one disputes the basic chemistry of ozone depletion – chlorine atoms from CFCs released into the environment can find their way into the stratosphere where they can chemically react with and “destroy” ozone.

It should be noted, however, that CFCs aren’t the only source of chlorine atoms in the stratosphere – Mother Nature, in fact, may supply most of them. Also, ozone is also continually being created so we won’t ever run out of ozone.

In any event, none of the alleged environmental and public health horrors of CFC-induced ozone “destruction” have ever been observed despite extensive study – one of the best kept secrets of environmentalism.

While overexposure to UV is a risk factor for some types of skin cancer and cataracts, no scientific study has ever demonstrated a link between ozone depletion and such overexposure or any health effects.

A December 2003 article in the journal Photochemical & Photobiological Sciences, for example, would only go so far as to say that “The potential health effects of elevated levels of ambient UV-B radiation are diverse, and it is difficult to quantify the risks.”

The absence of evidence linking ozone layer thinning with health effects isn’t surprising because the phenomenon was never thought (by experts, anyway) to lead to more than a trivial (10 percent) increase in UV radiation reaching the Earth’s surface.

As there is about a 5000 percent increase in UV radiation moving from the poles to the equator, a 10 percent increase in the mid-latitudes equates to a move 60 miles to the south – “hardly a source for health concerns,” says physicist Dr. S. Fred Singer of the Science and Environmental Policy Project.

It’s not even clear that ozone depletion, in its pre-phaseout heyday, ever increased the amount of UV radiation hitting the Earth’s surface. “There has been, of course, a determined search for a secular increase in [UV radiation] to match the presumed depletion of ozone. But no such trends had been observed,” says Dr. Singer.

And a little common sense about UV radiation goes a long way. Life flourishes in the tropics where UV radiation levels are far higher than in the quite inhospitable polar regions.

Yes, there is an “ozone hole,” but that label is more appropriately applied to the Montreal Protocol than the ever-changing thickness of the ozone layer over the Antarctic polar region.

Former Vice President “Ozone Al” Gore acknowledged in a recent presentation I attended that the real value of the Montreal Protocol was that it demonstrated the global political power of the environmental movement.

But while getting a junk science-fueled international treaty signed may have been a valuable political exercise for environmentalists, the Montreal Protocol can hardly be considered a success if it winds up needlessly depriving asthmatics of available, affordable and effective medication.

Steven Milloy publishes JunkScience.com and CSRwatch.com, and is an adjunct scholar at the Competitive Enterprise Institute.

Cancer Miracle or Mirage?

By Steven Milloy
June 06, 2003, FoxNews.com

The media and stock market are again atwitter with news of another supposed cancer breakthrough. Avastin (search), a drug developed by biotech giant Genentech (search), reportedly extended the median survival time of terminally ill colon cancer patients in a clinical trial by 4.7 months.

The news was formally released at last weekend’s meeting of the American Society of Clinical Oncology (search) (ASCO). The price of Genentech stock has risen by about 65 percent since mid-May when the news began leaking.

One biotech analyst said annual sales of Avastin could reach $2 billion as almost 150,000 Americans are diagnosed with colon cancer and 57,000 die from it every year.

And based on headlines such as the Los Angeles Times’ “New Drug Combinations Effective on Colon Cancer,” the Avastin claims sound exciting.

But since cancer breakthrough news is usually more smoke than fire, a closer look is warranted — especially since Avastin wasn’t effective in an earlier breast cancer trial.

It’s too bad a closer look isn’t possible.

Detailed information in standard study form about the Avastin trial isn’t available — not from the Duke University Medical Center, whose news release claimed Avastin’s efficacy was “proved,” and not from Genentech, whose market value increased by $15 billion on the news.

Both were happy to be contacted about the study, no doubt expecting more giddy and gullible reporting. But no detailed write-up was available. The Genentech spokesperson couldn’t even say when a study might be published.

Only a brief study summary or abstract was available, one omitting or glossing over key information and basic questions about the trial.

The trial involved 925 patients. About 800 patients were either given Avastin plus a standard chemotherapy or the chemotherapy alone. Another 100 patients were given Avastin in combination with another standard chemotherapy.

The abstract only contains results for the 800-patient treatment group. What happened in the 100-patient treatment group? Was Avastin effective there, too? If so, why not report it?

Avastin reportedly increased survival time by almost five months. But that claim relies on the major assumption that at the beginning of the trial, patients in the Avastin group, on average, had a similar expected survival time as patients in the chemotherapy-alone group.

Individual study subjects, though, likely had different types of colon cancer and were at different stages in the progression of their colon cancers. If the Avastin treatment group was, on average, at an earlier stage of colon cancer or had less aggressive colon cancers and metastases, it wouldn’t be surprising that their survival time is longer.

The researchers apparently hoped that random assignment of subjects to the Avastin and non-Avastin treatment groups would equalize the expected survival times of the treatment groups at the trial’s beginning.

This may have worked, but we just don’t know. Without some information about, and validation of the assumption, the touted results are based on a huge leap of faith.

The trial was multicenter in nature, meaning that patients were treated at several locations around the country. Such decentralization may give rise to a phenomenon known as “multicenter bias,” where the results from one study center may be skewed because of some systematic difference in the conduct of its part of the trial.

We can’t tell whether multicenter bias occurred in the Avastin trial because the data weren’t reported by a study center.

I asked lead researcher Herbert Hurwitz whether the study was peer-reviewed. He said it was reviewed by a committee of ASCO — the group putting on the medical conference where the results were announced.

But how could the committee perform a credible review with only the superficial abstract? No reputable journal would publish results without more. We must also wonder if the committee was truly objective since ASCO may have been eager to have such headline-grabbing claims announced at its annual meeting.

One final reason for requiring something more than “science by press conference” is that the biological mechanism by which Avastin is supposed to work, the blocking of blood vessels in tumors (anti-angiogenesis), hasn’t really panned out yet.

Based on studies in laboratory animals, anti-angiogenesis drugs were first touted several years ago in a front-page New York Times article that caused dramatic speculation in biotech stocks. But subsequent studies in humans have disappointed and biotech stock prices collapsed.

Given the huckster-ish history of anti-angiogenesis drug claims, Genentech and Hurwitz should realize more than a vague abstract is needed to show Avastin works. A detailed study would be a start, followed by more clinical trials.

Proven effective or not, terminally-ill cancer patients shouldn’t be denied Avastin or any other potentially helpful drug they are willing to try on their own dime. But cancer treatments shouldn’t be hailed until they are actually proven to work.

Steven Milloy is the publisher of JunkScience.com, an adjunct scholar at the Cato Institute and the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001).