Tag Archives: Big Pharma

The Puppy Protection Act Offers (Slim) Hope to (Some) Abused Pups

Congress.org reports today on bills recently introduced in both houses of Congress. The Puppy Uniform Protection and Safety (PUPS) Act (S 3424 and HR 5434) would “amend the Animal Welfare Act to provide further protection for puppies.”

The bills, from Sen. Dick Durbin (D-Ill.) and Rep. Sam Farr (D-Calif.), were introduced at the end of May and tail a Department of Agriculture inspector general report regarding federal investigations of breeders.

The IG report, released May 25, says large breeders who sell animals covered under the Animal Welfare Act (AWA, PL 89-544) online are exempt from inspection and licensing requirements “due to a loophole in AWA.” The IG says there are “an increasing number” of these unlicensed, unmonitored breeders.

The bills would require licensing and inspection of dog breeders that sell more than 50 dogs per year to the public (including online) and would also outline additional exercise requirements for dogs at facilities – such as having sufficient, clean space and proper flooring.

According to a press release, Durbin said he would work administratively with the USDA to fix problems at its Animal and Plant Health Inspection Services, and then introduce addition legislation if needed.

Supporting humane treatment of puppies would seem like a political no-brainer, right? As Liliana Segura pointed out on Twitter earlier today, what could be better in the upcoming midterm elections than “to be able to say ‘our opponents HATE puppies'”? Mainstream groups like the Humane Society have been pushing for legislation action on puppy mills for years, to little avail. (Click here to see video of a Humane Society raid on a massive puppy mill in Tennessee, and here to read some gruesome details from the USDA’s report on puppy mills.) Yet the bills are not exactly barreling their way through Congress; both are waiting for attention from agricultural subcommittees, and after two months, the Senate bill has only seven co-sponsors.

In addition, when it comes to animals routinely used in cosmetic testing, and animals (including puppies and dogs) treated cruelly in drug testing and medical research, the federal government has pretty much sat on its hands–or worse. To take one particularly galling example, the Physicians Committee for Responsible Medicine last year exposed an effort on the part of the National Institutes of Health to sell young constituents on the idea of animal experimentation. As Stephanie Ernst wrote on Change.org:

[T]he NIH promotes, on its Web site, a children’s coloring book that gives a skewed view of animal experiments. The coloring book implies that researchers are trying to cure animals that are already sick—rather than purposely infecting them with diseases—and ignores the fact that animals suffer and die in the process. The coloring book, entitled The Lucky Puppy, was produced by an industry trade group, the North Carolina Association for Biomedical Research, whose members have a financial interest in the continuation of animal research…

The book erroneously portrays the lives of animals in laboratories as pleasant and carefree. Published scientific research and numerous undercover investigations clearly demonstrate that animals in laboratories suffer pain and distress from experimental procedures and routine laboratory practices. The coloring book also makes misleading claims about the benefits of animal experiments, implying that research findings from experiments on animals are directly applicable to both the animals used in research and to humans.

The federal government is also actively engaged in protecting animal testing and experimentation against animal rights activists. Anyone who chooses to take action against an animal testing facility is not, as one would expect, subject to charges of breaking-and-entering or vandalism. Instead, they are branded terrorists under the notorious Animal Enterprise Terrorism Act; for actions in which no human being were harmed, they can end up serving long sentences in a federal supermax Communications Management Unit.  (See the blog Green Is the New Red for the best information on AETA.)

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Meet the Real Death Panels: The Truth About Age-Based Health Care Rationing

The latest issue of Mother Jones includes an article by me about the controversy over age-based health care rationing, which got transformed by the right into government “death panels.” Unfortunately, liberals have fallen into a different trap, because they refuse to take on the real enemies of affordable health care for all: the insurance companies, drug manufacturers, and other profiteers of our private health care system.

As a result, old people are being asked if we would be willing to give up some expensive, life-sustaining treatment so that our grandchildren can have health care. This is a bogus question, and a bogus “choice.” The real question, as I say in the article, is whether we should give up the treatment “so some WellPoint executive can take another expensive vacation, so Pfizer can book $3 billion in annual profits instead of $2 billion, or so private hospitals can make another campaign contribution to some gutless politician.”

It’s a long article, and I’m including just the opening here, with a link at the end to continue reading at the Mother Jones web site. Or you can read the whole thing at MotherJones.com by clicking here. And if you’re one of those geezers who still likes reading print and turning pages, the July/August issue is on newsstands now.

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From Mother Jones, July/August 2010

There’s a certain age at which you cease to regard your own death as a distant hypothetical and start to view it as a coming event. For me, it was 67—the age at which my father died. For many Americans, I suspect it’s 70—the age that puts you within striking distance of our average national life expectancy of 78.1 years. Even if you still feel pretty spry, you suddenly find that your roster of doctor’s appointments has expanded, along with your collection of daily medications. You grow accustomed to hearing that yet another person you once knew has dropped off the twig. And you feel more and more like a walking ghost yourself, invisible to the younger people who push past you on the subway escalator. Like it or not, death becomes something you think about, often on a daily basis.

Actually, you don’t think about death, per se, as much as you do about dying—about when and where and especially how you’re going to die. Will you have to deal with a long illness? With pain, immobility, or dementia? Will you be able to get the care you need, and will you have enough money to pay for it? Most of all, will you lose control over what life you have left, as well as over the circumstances of your death?

These are precisely the preoccupations that the right so cynically exploited in the debate over health care reform, with that ominous talk of Washington bean counters deciding who lives and dies. It was all nonsense, of course—the worst kind of political scare tactic. But at the same time, supporters of health care reform seemed to me too quick to dismiss old people’s fears as just so much paranoid foolishness. There are reasons why the death-panel myth found fertile ground—and those reasons go beyond the gullibility of half-senile old farts.

While politicians of all stripes shun the idea of health care rationing as the political third rail that it is, most of them accept a premise that leads, one way or another, to that end. Here’s what I mean: Nearly every other industrialized country recognizes health care as a human right, whose costs and benefits are shared among all citizens. But in the United States, the leaders of both political parties along with most of the “experts” persist in treating health care as a commodity that is purchased, in one way or another, by those who can afford it. Conservatives embrace this notion as the perfect expression of the all-powerful market; though they make a great show of recoiling from the term, in practice they are endorsing rationing on the basis of wealth. Liberals, including supporters of President Obama’s health care reform, advocate subsidies, regulation, and other modest measures to give the less fortunate a little more buying power. But as long as health care is viewed as a product to be bought and sold, even the most well-intentioned reformers will someday soon have to come to grips with health care rationing, if not by wealth then by some other criteria.

In a country that already spends more than 16 percent of each GDP dollar on health care (PDF), it’s easy to see why so many people believe there’s simply not enough of it to go around. But keep in mind that the rest of the industrialized world manages to spend between 20 and 90 percent less per capita and still rank higher than the US in overall health care performance. In 2004, a team of researchers including Princeton’s Uwe Reinhardt, one of the nation’s best known experts on health economics, found that while the US spends 134 percent more than the median of the world’s most developed nations, we get less for our money—fewer physician visits and hospital days per capita, for example—than our counterparts in countries like Germany, Canada, and Australia. (We do, however, have more MRI machines and more cesarean sections.)

Where does the money go instead? By some estimates, administration and insurance profits alone eat up at least 30 percent of our total health care bill (and most of that is in the private sector—Medicare’s overhead is around 2 percent). In other words, we don’t have too little to go around—we overpay for what we get, and we don’t allocate our spending where it does us the most good. “In most [medical] resources we have a surplus,” says Dr. David Himmelstein, cofounder of Physicians for a National Health Program. “People get large amounts of care that don’t do them any good and might cause them harm [while] others don’t get the necessary amount.”

Looking at the numbers, it’s pretty safe to say that with an efficient health care system, we could spend a little less than we do now and provide all Americans with the most spectacular care the world has ever known. But in the absence of any serious challenge to the health-care-as-commodity system, we are doomed to a battlefield scenario where Americans must fight to secure their share of a “scarce” resource in a life-and-death struggle that pits the rich against the poor, the insured against the uninsured—and increasingly, the old against the young.

For years, any push to improve the nation’s finances—balance the budget, pay for the bailout, or help stimulate the economy—has been accompanied by rumblings about the greedy geezers who resist entitlement “reforms” (read: cuts) with their unconscionable demands for basic health care and a hedge against destitution. So, too, today: Already, President Obama’s newly convened deficit commission looks to be blaming the nation’s fiscal woes not on tax cuts, wars, or bank bailouts, but on the burden of Social Security and Medicare. (The commission’s co-chair, former Republican senator Alan Simpson, has declared, “This country is gonna go to the bow-wows unless we deal with entitlements.”)

Old people’s anxiety in the face of such hostile attitudes has provided fertile ground for Republican disinformation and fearmongering. But so has the vacuum left by Democratic reformers. Too often, in their zeal to prove themselves tough on “waste,” they’ve allowed connections to be drawn between two things that, to my mind, should never be spoken of in the same breath: death and cost.

Click here to the rest at MotherJones.com.

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Newest Medical Combine: Delis and Hungry Docs

Over the last year or so, there has been a campaign to break the hold of the pharmaceutical companies on doctors. The aim is to get more transparency so as to show the true relations between the drug industry and doctors, which involves taking gift , getting exotic all-expense- paid vacations, signing their names to articles they didn’t write, and on and on. The ultimate goal is to expose and eventually stop these practices.

Among the most fervent of these efforts has been carried out by groups of medical students and doctors who try to stop drug companies from handing out free lunches to busy medical professionals, who are often in hospitals on their short breaks.

Now, the pharma-free lunch movement faces the wrath of the restauarant lobby, which in Massachusetts is said to face a serious loss of business due to the reduction in the numbers of lunches bought by Big Pharma for the docs. Restaurants in Massachusetts want the gift ban ended, according to BNET:

Statehouse Democrats say the ban, which prevents drug sales reps from delivering free sandwiches to doctors, has “severely impacted the profitability” of local businesses. Rep. Brian Dempsey told the Boston Business Journal:… “We’ve been hearing from device and biotech companies, the convention center and the restaurant industry, that this is causing additional problems during the worst recession in memory.

As BNET reports, a pumped up Jeff Norris from Twins Restaurant & Catering in Erie, Pennsylvania, tells EZ Restaurant Marketing, an outfit that counsels restauranteurs how to break into feeding docs:  

“I used to do 2 maybe 3 luncheons per week, and soon I was doing 2 or 3 luncheons PER DAY…Thru June 30th , 2004 I have done 4 TIMES the amount of business with drug reps than I did in ALL of 2003. My marketing is on cruise control. I have some offices REQUIRING drug reps to call me for their luncheons!”

In Los Angeles, for example, Dr. Lunch, an outfit that caters to docs,provides this testimonial from a Dr. Martin Levine: “My staff and I request their lunches repeatedly. We have always enjoyed the food and service provided by DR.LUNCH. The food is not only delicious, but always fresh. I highly recommend them for any event, whether it be your office or home. 

 BNET further reports:

Some doctors get so used to free lunches that they issue instruction sheets to sales reps, such as this delightfully specific one from a Baltimore doctor obtained by [the blog]Pharmalot: “(Please do not order wraps, several members of the office have not tolerated them well).”

And we’re not just talking sandwiches and chips. Free lunches can be elaborate. Angelo’s of Flemington, NJ, offers Tiger Shrimp sautéed in a pink cream vodka sauce with penne pasta.

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Supreme Court on Pfizer’s Pharmaceutical Colonialism

Victims and families protest outside the courthouse in Kano, Nigeria, in 2008. Photo: AFP.

While the media was chewing over the Supreme Court’s gun decision earlier in the week, another significant action passed with little comment. That was the court’s refusal to throw out a case brought under the Alien Tort Statute on behalf of Nigerians whose children died or suffered terrible damage in a Pfizer drug experiment.

The case is of considerable importance, because so many drug companies have conducted tests of new medicine’s abroad in poor countries, using the residents as lab rats in what some have dubbed “pharmaceutical colonialism.” The BBC reports:

The US Supreme Court on Tuesday declined to take up a case examining whether drug giant Pfizer could be sued in an American court for allegedly conducting nonconsensual drug tests on 200 Nigerian children in 1996. The action allows the case to move toward a trial. Eleven of the children died, and many others were left blind, deaf, paralyzed, or brain-damaged, according to court documents.

At issue in the Supreme Court appeal was whether the surviving children and relatives of the children were entitled to file a lawsuit in New York seeking to hold Pfizer responsible. Usually, such a suit would be filed in Nigeria. Lawyers for the children complained that Nigerian judges are corrupt and that the US court system holds the only promise of justice.

The suit was filed under the Alien Tort Statute (ATS), which empowers federal judges to hear civil lawsuits filed by non-US citizens for violations of the “law of nations.” Lawyers for Pfizer denied that the Nigeria experiments were conducted without the consent and knowledge of the children and their guardians. In addition, the lawyers argued that the children’s case should be thrown out of court because the alleged drug experiments are not the precise type of international law violation covered under the ATS. What made the high court appeal potentially significant is that the Supreme Court has declared that foreign plaintiffs may rely on the ATS to file lawsuits, but only in a few limited circumstances. The high court has not yet identified precisely which few cases may be brought and which may not.

For those interested in reading more on this grim subject, this long piece that appeared in Der Spiegel back in 2007 provides details on the Pfizer case. Sonia Shah’s 2006 book The Body Hunters uncovers other unethical drug trials throughout the developing world. And if you’re looking for some timely summer reading, John Le Carre’s 2001 book The Constant Gardener reimagines the story as a thriller, with Big Pharma cast as one of the leading villains of the post-Cold War world–which, of course, they are.

Drugsters in Academia: How Big Pharma “Educates” American Doctors

 The pharmaceutical industry has wormed its way into the hearts and minds of the medical professions in any number of ways—wining and dining doctors, sending them off to vacation in splendid spas, and even buying their names to put on industry-written articles promoting different drugs.

One little known facet of this drugster-doctor relationship is Big Pharma’s role in continuing medical education (CME) programs, which are important in keeping medical professionals informed and up to date on the fast developing profession. Of the $2 billion-odd spent on these programs every year, nearly half comes from the drug business, which not-so-subtly uses the education programs to push new drugs.

Last week a conference at Georgetown University called “Prescription for Conflict” pulled together experts from academia, government, and industry to discuss the question: Should industry fund continuing medical education? The main instigator here is a former colleague of mine named Adriane Fugh- Berman, a doctor and teacher at Georgetown University Medical School. Fugh-Berman long ago became the nemesis of Big Pharma with a stream of articles and talks questioning the different aspects of liaison between the drugsters and the medical profession. I worked with her helping to set up PharmedOut.org, a website that seeks to educate the public on these liaisons, in part through exposes, both written and on video.

The conference at Georgetown included few critics as candid as Fugh-Berman. Those gathered included polite academics with hedged criticism of industry funding, and regulators like Joshua Sharfstein, principal deputy commissioner at the FDA,  and Julie Taitsman, chief medical officer the Department of Health and Human Services, who presented a list of  the different laws protecting the public. By the time they finished, I was so frustrated with government bureaucrats that I was about ready to join the Tea Party (except that they, of course, would want to do even less to control the greedmeisters at Big Pharma).

One blunt critique came from Paul Thacker, an investigator for Senate Republican Charles Grassley, who has been the most visible Congressional muckraker on the doctor-drug company love-in. Thacker bluntly told the docs to get off their supercilious “who me?’’ attitude and come to grips with the scarcely believable conflicts of interest existing between the medical profession and the drug industry–conflicts that more often than not have been to the detriment of their patients.

The industry, as always, insists it isn’t doing anything bad–far from it. Big Pharma, its representatives would have you believe, is really performing a public service, trying to educate docs so they can do a better job. This conference, however, offered a different point of view, in the statement of an anonymous “pharmaceutical executive,’’ who admitted industry involvement in “CME has the potential for inappropriate promotional messaging and influence.’’ 

The anonymous exec went on to state:  “Typically,companies make CME investment decisions at annual budget meetings.  The Sales and Marketing divisions dominate deliberations.and distribution of CME cash.’’ In deciding what institutions are to get money, he continued, “large volume, influential institutions are not likely to be rejected…Friendly institutions, as defined by access and volume, are more likely to receive grants than those that favor another company’s products. Grants may also be made in support of programs including particular KOLs [key opiniong leaders] whose opinions resonate with the promotional plan…Similarly, those known for positions antithetical to the company’s promotional plan are less likely to be supported.’’

In conclusion, the exec said, “CME contributions are commercial decisions,’’ and, finally, “CME is not compatible with commercial intervention.’’ Too bad it takes a drug company whistleblower to make this statement of the obvious, rather than the medical organizations and government regulatory agencies who are supposed to be looking out for us.

Will Drug Pushing Docs Get New Rules for Serving Big Pharma?

Bitch. Bitch. Bitch. That’s all the money-grubbing clique of pharma groupie docs do when anybody even remotely questions their right to rake in thousands of dollars, by signing their sacrosanct names to somebody else’s “research” paper pushing a new drug. Now the American Heart Association has taken a tiny step forward by announcing a rule governing the publication of drug company promotional material. John Mack describes the situation on his Pharma Marketing Blog, in a post entitled, “Are Docs Being Banished from Pharma’s Garden of Eden?”

“It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector,” said Francis Collins, director of the National Institutes of Health, at a meeting in Bethesda, Md. At issue is a decision by the American Heart Association (AHA) to ban pharmaceutical industry employees from making medical education presentations later this year at the AHA’s annual scientific sessions (see “Drug firms banished from medical talks“)….Wow! It’s as if physicians were banished from an Eden where they enjoyed the fruits of the tree of knowledge made accessible by the pharmaceutical industry. To some, it’s a development of biblical proportions that deserves an appropriate image.

 And here’s the new rule:

“In compliance with ACCME requirements, employees of a commercial interest entity cannot be the presenting author of the abstract. A commercial interest is defined as any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients. For our purposes, an employee is defined as someone who is directly working for the commercial interest as their primary employer and the commercial interest provides their primary source of income. A person acting as a contractor to a commercial interest, providing consultation, or other services secondary to their primary appointment at, for example, a university, would not be considered an employee.”

“If the abstract is selected for presentation (oral or poster),” says AHA, “the employee of the commercial interest cannot present but must select another author.”

What this means is that an abstract that is authored solely by a physician or physicians DIRECTLY employed full-time by a pharmaceutical company can be blocked. Otherwise, another, non-pharma employee author can make the presentation. There is almost always other non-pharma authors, including the physicians who ran the clinical studies being reported. Also, ghostwriters can make presentations, as indicated by this FAQ from AHA:

“Q: I am the primary author of an abstract and designated as the presenter. I am currently employed by a home health agency. Can I still present my abstract?

A. Yes, the ACCME does not consider providers of clinical service directly to patients to be commercial interests.”

It’s really hard to believe that none less than the director of the  National Institutes of Health gets openly involved in supporting Big Pharma, but that’s Washington these days.

In any case, this rule doesn’t really curb doctors; it stands to enlarge their market. Now, more docs can charge more money to sign papers they haven’t written, in order to meet the AHA standards, with the apparent backing of the National Institutes of Health. Talk about snakes in the grass!

Be sure to visit Pharma Marketing Blog for Mack’s illustration, and his always entertaining posts.

How Obama Helps Docs Clean Up their Act

Doctors,now bitching about getting screwed by the Obama health reform, ought  to be raked over the coals for turning themselves into  sales people for Big Pharma. A Big Pharma rep–especially a hunk or pretty woman–can appear at a doctor’s office with a box of candy or bunch of flowers for the secretaries or nurses. The door to the inner sanctum of the physician’s office is quickly opened..There, the sale rep chats up the doctors,asking them about their children, where they last took a vacation, and their proverbial game of golf. Then they invite these medical professionals  to a cozy dinner  in a plush but quiet restaurant for a discussion about new research showing how a drug approved for one purpose can actually be used for some other non-appproved purpose. Or the sales person  may issue the doctor an invitation to speak at a medical conference for big bucks, or even better,a deal to receive a lot of money for signing an article he or she  didn’t write.

   Among the little known pluses of the health reform is incorporation of the Sunshine Act which requires drug companies make public the amounts of money they pay physicians for their “services.” What this should mean is that when you go to the doctor and he happily tells you of the latest pill for the “gotta go” problem or a new  pill to control what might just be the beginnings of depression, or some new medicine to manage  eyelash length, you can go to the internet,look him up, and see who has paid her for doing what. In his blog Daniel Carlat,provides the details.Here is an excerpt:

  …. now that the Sunshine Act is officially the law of the land, what, exactly, are its provisions, and how might it affect medicine? … Essentially, the law requires that all drug and device companies report all payments made to physicians and teaching hospitals. This includes money for marketing activities, such as promotional talks and consultation, but also includes research grants, “charitable” contributions (which usually come with some promotional strings attached), and funding for conferences, whether CME or otherwise.

Given that so many drug companies have already published registries of physician payments, one might reasonably ask whether this act was actually needed, and whether it will really accomplish anything new. It was, and it will, and here’s why.

As noted by Eric Milgram on his Pharma Conduct Blog,the existing company sponsored disclosures provide few details and are formatted in such a way that they are “translucent” rather than “transparent.” As a patient, physician payment registries are important because they would presumably allow me to easily look up my doctor, and find out if he or she has been paid to push that new and expensive drug that was just prescribed for me. The current registries don’t provide that level of detail, and they make it hard or impossible to conduct efficient searches.

The Sunshine Act fixes this problem. Companies will be required to report names, addresses, the amount of the payment, the date of the payment, and the precise nature of the “service” provided by the doctor. Not only that, but if the payment was for a promotional talk, the company will have to disclose the name of the drug the doctor was pushing. Thus, for example, Eli Lilly’s current registry would allow you to find out that a doctor made $50,000 in 2009 performing what is vaguely (translucently) described as “healthcare professional education programs.” But the Sunshine Act registry will tell you that your doctor made $50,000 for marketing Zyprexa in 2009. In fact, the Zyprexa speaker’s payments will be broken down by date, so you might be able to discover that your doctor got a fat check exceeding your annual salary on the day before he wrote out a Zyprexa prescription for you.