Physicians Committee for Responsible Medicine – Page 6

Neal Barnard's Tired Lies about Animal Research

Neal Barnard wrote one of his boilerplate op-eds filled with nonsense for a pro/con debate in the Orlando Sentinel with Frankie Trull.

There’s the usual nonsense. Barnard keeps claiming for example, that the diet drug combination fen-phen was tested on animals and found to be safe, but later had to be pulled. In fact, fen-phen was an off-label combination of fenfluramine or dexenfluramine and phentermine. The combination was never tested extensively in animals and never approved by the FDA.

And, of course, Barnard conveniently forgets that anyone looking at the animal research on these three drugs would have quickly noticed that the combination was likely to cause problems. Fenfluramine was supposed to be used for only a few weeks at a time, not for the months and years that some patients were on it. Similarly, in approving phentermine, the FDA explicitly noted that there was no safety data available on its usage in excess of 1 year and urged caution.

Yet when the drug was finally pulled, the average length of time patients had been on fen-phen was 9 months. Doctors were routinely ignoring the FDA’s recommendations on fenfluramine and dexenfluramine, and for phentermine as well. The animal and human testing worked fine, physicians simply chose to ignore the limitations on these drugs (and frankly I’m skeptical of claims that fen-phen was dangerous, but that’s a debate for another day).

Barnard also repeats the animal rights nonsense about the U.S. General Accounting Office’s 1990 report, FDA Drug Review: Postapproval Risks, 1976-85 (I’ve placed a copy of the full report on my web site in PDF form here).

According to Barnard,

The U.S. General Accounting Office found that, of all new drugs marketed during a 10 year period, a majority — 52 percent, to be exact — had seriously toxic or even fatal effects that were not predicted by animal tests. And animal tests allow more minor side effects — rashes, nausea, diarrhea, etc. — to slip through routinely.

This is an excellent example of how animal rights activists distort the truth. You’d think from reading Barnard’s article that the GAO report is about animal tests. You would be wrong.

In fact what the GAO report actually focuses on is the amount of time that the FDA spent considering a new drug application. It found, not unsurprisingly, that the odds of a new drug having to be relabelled or recalled was strongly correlated with the amount of time the FDA took to review the new drug application. The longer the FDA spent reviewing the NDA, the less likely the drug was to require relabeling and, conversely, the faster the FDA processed NDAs, the more likely it was that those drugs would later require some label changes.

The reader would also never know from Barnard’s summary that of the 198 drugs that the GAO survey examined, only 6 were withdrawn completely. The rest of the drugs simply had label changes warning specific patient subpopulations to avoid the drug or carefully follow monitoring procedures to prevent adverse events.

The real issue here is one of weighing risks. At one extreme, the FDA could spend two hours reviewing a new drug application and vote to approve or disapprove. This would certainly lead to an unacceptably high level of drugs that caused severe adverse events. On the other extreme, the FDA could require every new drug to undergo a rigorous 25-year testing procedure. Not only would no companies be interested in producing new drugs under that regimen, but many more people would die due to a lack of medications than are put at risk by less extreme measures.

The issue for the FDA and society is how we want to manage that risk and where we draw the line, with the full knowledge that risk cannot be eliminated completely from the calculation.

The FDA report, unfortunately sidesteps this issue in that it never even addresses whether or not the FDA has achieved an adequate balance, but regardless it certainly is not critical of animal research and its conclusions, if anything, would be a call for additional levels of animal testing, not less.

Sources:

Experiments on animals ineffective, unnecessary. Neal Barnard, The Orlando Sentinel, April 7, 2002.

FDA Drug Review: Postapproval Risks 1976-1985. U.S. General Accounting Office, April 1990, GAO/PEMD-90-15.

Robert Cohen Goes Off the Deep End, Part I

In mid-January the Center for Consumer Freedom issued a press release that was the first group I’m aware of to point out that Physicians Committee for Responsible Medicine had been actively working with Stop Huntingdon Animal Cruelty. According to the press release,

The ActivistCash.com profile of Physicians Committee for Responsible Medicine reveals that PCRM’s Neal Barnard recently engineered a letter-writing campaign with Kevin Jonas of the violent animal rights group known as SHAC. Jonas used to be known as Kevin Kjonaas, back when he was a spokesperson for the Animal Liberation Front (ALF), a militant group labeled terrorists by the FBI.

SHAC is singularly dedicated to dismantling the Huntingdon Life Sciences company, a UK firm which (like most respectable biologists) recognizes that most breakthroughs in the study of human diseases come from research using animals as test subjects. Huntingdon Life Sciences’ work includes animal research to find new treatments and cures for Parkinson’s, Alzheimer’s, cancer and epilepsy. SHAC activists have chosen to make their feelings known by fire-bombing automobiles, smashing windows, assaulting research employees, and targeting individual investors for round-the-clock harassment and intimidation.

Since PCRM is joined at the hip with People for the Ethical Treatment of Animals, including through a dummy nonprofit which the CCF also uncovered, this raises a lot of questions about both PETA and PCRM.

Of course to Robert Cohen, who really seems to be losing it these days, the connection between PETA, PCRM, and SHAC is of course that there is a conspiracy afoot by the dairy industry!

Citing CCF’s recent advertising campaign against PETA, Cohen distributed an e-mail wondering,

Where do restaurant and tavern operators [which CCF represents] get the financing for multi-millions of dollars worth of ad revenue? How do restaurant operators carefully coordinate attacks against Neal Barnard on the same day the dairy calcium summit begins, and the same day that CBS ran their biased milk story, sabotaging Neal Barnard by not clearly portraying the NOTMILK message? How were the dairy industry press release and the CCF press release posted within an hour of each other? Coincidence? Ha! Coincidence of this type do not happen.

No, it could not possibly have been that two groups with strong views about PCRM happened to release press releases about PCRM on the same day because PCRM had an upcoming event scheduled. No, it had to be a conspiracy between CBS, CCF, the dairy industry, and probably the tooth fairy as well.

Cohen continues ranting that,

This is carefully plotted warfare. The battle lines have been drawn. To accuse Neal Barnard of being a terrorist is to take advantage of a political and social climate that equates terrorism with the vilest of anti-American acts. Neal Barnard merits a Nobel Peace Prize for his efforts, not the label of terrorist.

Well, they did give Arafat a Nobel Peace Prize, so maybe one is not out of the question for Barnard. On the other hand, Cohen is simply lying when he says that CCF accused Barnard of being a terrorist. Rather, CCF simply noted that Barnard is actively working with an individual, Kevin Jonas who is an outspoken advocate of violence and, before doing the SHAC gig, was a spokesman for the Animal Liberation Front.

I’m sure a lot of people would like to hear Barnard’s explanation as to why he’s working with Jonas — for some reason PCRM does not mention that little tidbit anywhere on its web site as of February 2002.

Of course this is the same Robert Cohen who thinks the diary industry was being conspiratorial for trying to hold an even last year that didn’t involve animal rights protesters. It is Cohen who is left to babble on about soldiers and wars.

Source:

Center for Consumer Freedom Says Anti-Milk Activists Linked to Animal Rights Terrorists. Center for Consumer Freedom, Press Release, January 17, 2002.

WAR Declared on NOTMILK Movement. Robert Cohen, E-Mail Communication, January 21, 2002.

The Real Misinformation Campaign is PCRM's

Physicians Committee for Responsible Medicine has been waging an all out attack on the dairy industry which PCRM claims is “conducting a massive misinformation campaign.” But Harvard professor Daniel Cramer complains that PCRM has been misusing his research studies into dairy products.

Over the past three years, PCRM has repeatedly cited Cramer’s research as evidence that consumption o dairy products contributes to cancer. Cramer, however, told CNSNews.Com that this is a misrepresentation of his research. According to Cramer,

We don’t have the scientific proof to say that it [milk] has definitely been linked to cancer. I think that particular group has their own sort of agenda, of not wanting milk production around, and cows to be utilized. Their agenda is that [they] don’t want . . . cows exploited or they want everybody to be vegetarians.

CNSNews reports that Cramer did concede there are some links connecting lactose consumption with cancer in mice, but that that does not prove the sort of definite link between milk and cancer that PCRM claims. Besides which, of course, PCRM’s position is that research with animals is inherently invalid, so they would certainly dismiss even this thread of evidence.

When CNSNews tried to get PCRM’s reaction to Cramer’s comments, it reports they were told by PCRM communications director Simon Chaitowitz that, “We have nothing to say about this.” (PCRM with nothing to say? Who would have thought that day would ever arrive?)

CNSNews also notes that a researcher that PCRM cited back in October as providing evidence against milk also disputes PCRM’s use of her research.

In that case, Dr. June Chan published a study in the American Journal of Clinical Nutrition that hypothesized a causal connection between milk and prostate cancer. PCRM issued a press release with Neal Barnard chiming in that “there is every reason for men to avoid cow’s milk altogether.”

But when contacted by CNSNews, Chan had a different take on her research. “We do not recommend that people change their diets or stop drinking milk,” Chan told te news organization.

Kudos to CNSNews.Com for pursuing this story and getting the real story rather than just the smoke and mirrors that PCRM would like people to see.

Source:

Harvard Prof Claims Misuse of Data To Push Anti-Milk Agenda. John Rossomando, CNSNews.Com, January 23, 2002.

Lies, Damned Lies, and PCRM Claims

Steve Milloy wrote an excellent opinion piece for Fox News today (Animal Rights, Research Wrongs) attacking People for the Ethical Treatment of Animals and other animal rights groups. One of the groups Milloy defends is the March of Dimes. Since animal rights groups claim animal research into birth defects has done nothing but waste money, lets take a look at the lies of an animal rights group, Physicians Committee for Responsible Medicine, and compare it to the reality of what the research community has accomplished.

Milloy notes that the March of Dimes 2001 National Ambassador is a six year old boy who is alive today because of lung surfactant therapy. Lung surfactant therapy was developed thanks to animal research that the March of Dimes helped sponsor. Briefly, when you breathe your lungs contract. Lung surfactant is the substance that makes them expand again. Many infants born prematurely do not produce enough lung surfactant, and as a result their lungs tend to collapse which leads to increased mortality.

PCRM has a different take on the role of animal research and the March of Dimes in finding an effective treatment for lung surfactant deficiency. On the CharitiesInfo.Org web site, PCRM claims,

8. Did surfactant therapy for premature infants depend on animal experiments as the March of Dimes claims?

No. Surfactant is a natural compound that allows the lungs to operate normally. It was discovered in experiments using animal and human lung specimens in the late 1950s. Although some animal lung specimens were used, human lung specimens could have been used alone. Three years after its discovery, researchers demonstrated that premature infants have no surfactant in their lungs, but that the substance is present in the lungs of more mature infants, children, and adults. Within a few years, trials had begun administering this substance to infants with lung problems. Human studies continue today to improve surfactant therapy for infants.

As with most animal rights lies there is a grain of truth to this account, but if human studies were all that was needed to create lung surfactant therapy, it is a bit odd that the most effective such therapy is made from the lungs of calves. Here’s the reality.

In the mid-1950s a Boston-area physiologist, John Clements, discovered lung surfactant. He soon figured out that the substance’s function was to prevent lung collapse. A few years later in 1959, Mary Ellen Avery, a Boston-area pediatrician, discovered that premature infants born with a disorder called Hyaline Membrane Disease lacked lung surfactant which was the reason their lungs were collapsing.

Now if you take the PCRM account at face value, that settles it. Lung surfactant was discovered, and researchers knew that surfactant deficiency was the major cause of lung collapse in premature infants. So it was just a simple matter of developing a treatment and applying it to babies, right? Not by a long shot.

PCRM notes that “within a few years, trials had begun administering this substance to infants with lung problems” (emphasis added). What they forget to tell the reader is that a surfactant treatment wasn’t actually approved by the U.S. Food and Drug Administration until 1989(!) Finding a way to treat surfactant deficiency wasn’t quite as easy as PCRM pretends it was.

The first major treatment available was due to extensive research in sheep, not human beings. Researchers in New Zealand and the United States demonstrated that giving pregnant sheep steroids increased the rate at which fetal lungs developed, which in turn led to the development of surfactant in the lungs more quickly. Clinical trials in humans bore out the usefulness of delaying premature labor 24-48 hours and administering steroids to promote lung growth.

The introduction of ventilators in the early 1970s specifically designed to prevent lung collapse was also an important boon for the survival rates of premature infants.

Research into finding a safe, reliable surfactant replacement therapy continued through the 1970s and 1980s, much of it highly dependent on animal research. In fact when the U.S. FDA finally approved two surfactant replacement therapies, animal byproducts were the major component of one of the therapies. The natural surfactant replacement therapy is most commonly made from the extracts of calf lungs, though pig lungs and human lungs are occasionally used as a source as well. There is a synthetic surfactant available, but studies in both human beings and animals have tended to indicate that it is not as effective as that derived from bovine sources. On reason offered by the differing efficacy is the presence of proteins in the natural surfactant replacement which are absent in the synthetic replacement.

Far from animal studies being irrelevant, they played a fundamental role in developing a viable surfactant replacement therapy. So PCRM, take a deep breath and relax. Thanks to animal research, premature infants can have the same luxury.

Sources:

Why animal experiments fail in birth defects research. Physicians Committee for Responsible Medicine, undated.

Surfactant Replacement Therapy. Victor Chernick, Canadians for Health Research.

Hyaline membrane disease. Discovery.Com.

New Studies Of A Liquid Of Life — Lung Surfactant. Science Daily, August 23, 1999.

Natural surfactant extract versus synthetic surfactant for neonatal respiratory distress syndrome. Roger F. Soll, National Institutes of Health, February 1999.

Animal Rights, Research Wrongs. Steve Milloy, Fox News, June 29, 2001.

Story Correction: How I Let A Neal Barnard Lie Slip Through

Chalk this one up to writing for the web. Last week I wrote a story about the Physicians Committee for Responsible Medicine’s outrage over the death of laboratory animals in flood-ravaged Texas. Neal Barnard complained that research facilities should spend more of their money on flood evacuation plans, and I retorted that maybe if they didn’t have to spend so much on security keeping animal rights activists from getting into the laboratories, that they would have more money to spend getting lab animals out after floods.

Of course, Barnard’s claims turned out to be just the latest piece in a long line of misinformation from PCRM. In fact researchers at The University of Texas Medical School did have an evacuation plan for the animals, and were devastated when flood waters came on so rapidly that despite repeated efforts they were unable to evacuate the animals.

The Houston Chronicle interviewed the Texas Medical Center’s directory of veterinary medicine Chris Smith who noted that as soon as the rain began pouring down, attempts were made to reach the animals. Unfortunately tropical storm Allison just brought to much rain down too quickly for such a rescue to succeed.

How bad was the flooding. Americans for Medical Progress noted in its e-mail newsletter that people on the scene said it was a true flash flood, with one facility accumulating 9 feet of water in only half an hour.

Contrary to Barnard the center, like other research facilities in the flood prone area, had a flood evacuation program and had successfully evacuated animals on previous occasions when the area was threatened by hurricanes.

In this case researchers (and many others) were caught off guard when Allison temporarily lost strength and its severity downgraded, only to reform very quickly and begin drenching the area with torrential rains.

Although People for the Ethical Treatment of Animals and PCRM both tried to use the lab animal deaths as part of their anti-research campaigns, it was left to animal rights activist Rick Bogle to elevate the deaths into absurdity as only he can. Posting on the Primfocus e-mail list, Bogle mocked statements by Smith that scientists working with monkeys who had died (the animals were primarily used for behavioral research) had developed close relationships with the animals and would grieve for the lost primates. Bogle wrote,

It is a hideous notion that those who infect, experiment on, and otherwise torment animals will attempt to sell the public on the absurdity that they have “close relationships” with the animals under their control. And indeed, if such is the case it can be seen as the close relationship the Nazi doctors had with the Jewish subjects of their own experiments. Mengele had little pet Jewish children who he treated quite differently from the rest.

Sources:

Drownings of 78 monkeys, 35 dogs lamented by UT veterinary official. Eric Berger, Houston Chronicle, June 15, 2001.

PETA, PCRM use tragic lab animal deaths in Houston flood as media opportunity to advance anti-research agenda. Americans for Medical Progress, Newsletter, June 15, 2001.

Re: primfocus: Drownings of 78 monkeys, 35 dogs lamented by UT. Rick Bogle, e-mail to Primfocus list, June 15, 2001.

Correction: It is the policy of this web site to correct all errors of fact. When this story was first published, it inaccurately characterized the nature of the research projects for which the primates killed by the flooding were being used. According to the Houston Chronicle, “The monkeys . . . were used largely to study behavioral sciences.” AnimalRights.Net regrets the error.

How PCRM Distorts Medical Research

A Tennessee newspaper recently provide an excellent example of how the Physicians Committee for Responsible Medicine distorts genuine medical research. Notice the difference between the reporter’s accurate summary of a recent study about dairy products and prostate cancer, and Neal Barnard’s snap judgement,

A recent study by the Harvard School of Public Health raised the possibility
that consuming lots of dairy products could modestly increase the risk of
prostate cancer. The study stressed the case was far from settled and
recommended further study of calcium’s effects on health.

“Dairy products cause hormonal changes in a man’s body that increase the risk
of prostate cancer,” said [Neal] Barnard, a psychiatrist and nutrition researcher
with Georgetown University.

For the activists, any study which finds a correlation for something they agree with becomes instant proof that they are right, while studies that find correlations which the activists don’t agree with (such as those finding some advantages for eating fish) are either ignored or dismissed out of hand.

Source:

Group Targets Mississippi Because Of High Prostate Cancer Death Rates. The Commercial Appeal (Memphis, Tennessee), June 13, 2001.