MedPage Today Features Two Disturbing Articles on Drug Company Influence on Medical Boards, Medical Schools and Practice Guidelines

In both articles, the flash point is the use and abuse of opioid painkillers.

Some people with intractable pain (cancer or non-cancer) that has not responded to other methods, are legitimate candidates for opioid prescriptions. But as with all other medications, the goal of the pharmaceutical companies regarding opioids is to sell as many pills as possible, thus fulfilling their fiduciary duty to maximize shareholder profit.

Prescriptions for narcotic painkillers soared so much over the last decade that by 2010 enough were being dispensed to medicate every adult in the U.S. around-the-clock for a month.

Fueling that surge was a network of pain organizations, doctors and researchers that pushed for expanded use of the drugs while taking in millions of dollars from the very companies that made them, a Journal Sentinel/MedPage Today investigation found.

Last year, the Journal Sentinel/MedPage Today found that a University of Wisconsin-Madison based organization had been a national force in helping liberalize the way opioids are prescribed and viewed. During a decade-long campaign that promoted expanded use of opioids — an agenda that critics say was not supported by rigorous science — the UW Pain & Policy Studies Group received $2.5 million from makers of opioid analgesics.

After that article was published last April, the UW Pain group said it had decided to stop taking money from the drug industry.

But the UW Pain group is just one link in a network of national organizations and researchers with financial connections to the makers of narcotic painkillers.

Because Big Pharma has essentially unlimited deep pockets (at least in comparison normal mortals) with which to bestow its largesse on any organization connected to chronic pain, and does not hesitate to use this power, we’re looking at an issue of monumental proportions.

This story is going to keep growing larger until major changes are made.


Air Pollution Linked to Heart and Brain Risks

If presidential and congressional candidates who talk about defunding, disempowering, or eliminating the Environmental Protection Agency are successful, expect a great deal more of this. On pollution, the market does not regulate itself. Profits are privatized and costs are socialized.

That is the message of three new studies this week that found, collectively, that people exposed to higher levels of air pollution have a greater risk of stroke, heart attacks and cognitive deterioration.

The impact of pollution on the heart and brain was seen over both the short and the long term. One nationwide study that followed nearly 20,000 women over a decade found that breathing in levels of polluted air like those commonly found in most parts of the country greatly accelerates declines in measures of memory and attention span. Another study in Boston found that on days when concentrations of traffic pollutants went up, so did the risk of stroke. The odds climbed by more than 30 percent even on days classified by the federal air quality index as “moderate” pollution days, which is intended to correspond to a minimal danger to health.

“At levels that the Environmental Protection Agency says are safe, we’re seeing real health effects,” said Gregory A. Wellenius, an associate professor of epidemiology at Brown University and lead author of the study linking pollution to stroke. “We saw these effects within 12 to 14 hours of when pollution levels went up.”

Corporations and Researchers Routinely Ignore Legal Requirement to Publish Clinical Trial Data

This federal rule requiring more transparency in clinical trials reporting was a good first step toward making it harder to fool the medical journals and the public. But unenforced, it is worthless. A 22% reporting rate speaks for itself, loudly.

From Merril Goozner’s Gooz News blog:

Three leading Democratic Congressmen are wondering why companies and researchers who run clinical trials are systematically failing to file final outcomes data on as required by the 2007 FDA reform law. A series of articles in January in the British Medical Journal found that only 22 percent of 738 trials reported in 2009 had outcomes data.

In a letter to FDA Commissioner Margaret Hamburg and NIH director Francis Collins, Reps. Henry Waxman, Edward Markey and Diana DeGette, all Democrats, asked the government officials if the journal’s findings were accurate, and whether the agency had fined any companies or researchers for failing to publish their outcomes data. Research sponsors can be fined up to $10,000 a day for failing to report results.

Why is this important? Clinical trial sponsors must register a trial on prior to its start if they want to publish its final results in any of the leading medical journals. Journal editors demanded that so the initial protocols could be checked in advance of publication as part of peer review. That ensures sponsors won’t cherry pick data, lower the bar on outcomes measures mid-stream or engage in other research tricks to resuscitate a failing trial. Publication of results also provides outside researchers with the raw data needed to conduct meta-analyses of multiple trials. If fewer than one in four trial sponsors are following through, it defeats the whole purpose of the registry.


Interview with Harriet Washington (Part IV): Erosion of Informed Consent and Using Poor Patients to Test Drugs They Cannot Afford to Purchase

Consent and Non-Consent

I learned a great deal from the section of your book on informed consent and other forms of consent. Anyone who has been to a health practitioner’s office in recent years is at least somewhat familiar with signing an informed consent form. Could you explain this concept and also the related but very different concepts of presumed consent and community consent?

Informed consent is more than a signed piece of paper. I don’t blame people for thinking that it is because even some physicians tend to equate informed consent with the signature on that paper. The signature is one piece of evidence that you could offer in support of your claim that there is informed consent, which for a research study requires a detailed discussion that runs down all the information that’s known about the study, what it’s trying to do, how and why it was designed, and what the patient’s options are if they choose not to participate in the study. You must reveal to them all the known risks and logically anticipated risks.

As the study progresses, when new developments occur (perhaps it’s that the medication is especially helpful for one group of people, or that some people are having some awful adverse effects), all of this needs to be conveyed to the research subjects. Also, patients need to know that they have the right to leave the study at any time.

So this is about preserving the rights of the patient or research subject, allowing him or her to make choices freely, based on accurate information.

Yes. With true informed consent, the patient is in the best position to determine whether participating in the study is the best course for him or her. But even the best job of informed consent can’t tell one everything. There are things the investigator may not know about a drug or a device — that’s why it’s being tested. So informed consent is not a guarantee, but it’s your best possible avenue for preserving the subject’s right to making an informed decision. It’s about protecting people.

But unfortunately, in this country, we have started falling away from informed consent in ways that lack transparency. People assume that in every medical research study, you are going to be given the benefit of informed consent. In reality, we now have exceptions written into the law. In certain emergency medicine studies, you do not have to tell the person what you’re doing. You don’t have to explain and you don’t have to get permission.

This is what’s known as “presumed consent?”

Yes. Actually there are a variety of forms of consent that are misleading. They have the word “consent” in their name but they do not constitute informed consent. Presumed consent means that if there is a study going on, the researcher does not even have to tell you that they are involving you in the study. This not only applies to research studies; it can pertain to the taking of tissues.

In half the states of this country there are cities where if you die, the coroner has the right to take parts of your body and use them for research or transplantation. There are large fees paid; a great deal of money changes hands. No one has to tell your family that this has been done. In Philadelphia, corneas are routinely taken from people who have passed away and this is sanctioned by law. The families of the victims are not informed that this has been done. That is presumed consent.

Interview with Harriet Washington (Part III): Withholding Data from Journals and Flooding the Airwaves with Misleading Ads

Direct-to-Consumer Drug Ads: Banned Nearly Everywhere Yet Legal in the U.S.

Since the 1990s, the U.S. has allowed drug companies to advertise medications directly to the public. This is banned throughout Europe, as well as Canada and many other nations. Why does the U.S. have an outlier position on this?

Direct-to-consumer advertising of prescription medications is banned in every country except for the U.S. and New Zealand. Nobody else allows the corporations to do this, for obvious reasons. When you try to market a drug to physicians, the physicians may not be given all the information they need to evaluate the drug claims, but they do have a medical education and experience that helps them to evaluate the claims, to exercise some skepticism and to bring some rigor to deciding whether or not the drug is worthwhile.

That’s not true of everyday people. They don’t have the tools, by and large, to evaluate the claims. They don’t have the tools, by and large, to listen to the advertising message and spot the logical holes in the message. So that’s why hardly any countries allow their citizens to be duped in this manner.

I’ve watched these ads and I’ve written about them for journals. Many have frank falsehoods in them. I’m not talking about subtle deceptions or sly language; I’m talking about lies. When these become especially egregious, the FDA will write them a letter warning them to stop. The response of the companies is to keep going as long as they can because it’s worth it to them. A slap on the wrist from the FDA is nothing compared to the huge amounts of drugs they can sell to an unsuspecting public. These ads can be very deceptive and give limited information.

More after the jump.

Teaching Hospitals’ Poor Safety Ratings: Due to Poor Safety or Better Record Keeping?

This Kaiser Health News article, produced in collaboration with the Boston Globe and the Washington Post, describes Medicare’s new hospital safety ratings, which surprisingly found that the nation’s major teaching hospitals were nearly 10 times as likely as other hospitals to be rated as having high rates of serious complications.

This new ratings system is mandated by the Patient Protection and Affordable Care Act. The stakes are high not only for obvious reasons of patient safety but also because Medicare and other insurers are moving toward linking reimbursement rates to quality rather than quantity of care. Safety ratings are one way that quality care is measured.

Teaching hospitals are crying foul, claiming that it is their more thorough record-keeping, rather than actual safety problems, that the Medicare ratings are capturing.

Officials at many of the hospitals listed as having high rates of complications say the measures are distorted in ways that exaggerate problems at hospitals that treat lots of complicated cases or very sick patients.

“Not all of these metrics are ready for prime time,” George Blike, who oversees safety at Dartmouth Hitchcock Medical Center and Mary Hitchcock Memorial Hospital in Lebanon, N.H., which Medicare ranked as having a high rate of complications. “It’s unfortunately going to create a lot of confusion for the public.”

The Medicare data show high rates of serious complications for elderly patients at 3 out of 10 major teaching hospitals, including some of the biggest institutions in Boston, Philadelphia, Los Angeles, Cleveland and Chicago.

I find it difficult to believe that institutions like Mount Sinai, Geisinger, Cleveland Clinic, Dartmouth Hitchcock and the like are less safe than the other hospitals. And because statistical measures of quality are now so deeply embedded in health policy planning, this is an issue that will have to be sorted out as quickly as possible. 

(h/t The Schwartz Report).

Interview with Harriet Washington (Part II): The Many Tentacles of Corporate Funding

Click here to read the introduction to this four-part interview or click here to read Part I.

Pulling the Plug on Unprofitable Research

Can you give another example?

Consider the case of Dr. Chris Parish in Australia, who was working on a very promising liver-cancer drug, PI-88, that was about to go into the final stage of trials. It had performed well in trials and looked as if it would be very effective. Liver cancer is a major killer worldwide. It’s the third largest cause of cancer deaths around the globe and we don’t have many drugs for it. And yet, Progen Pharmaceuticals Limited, the company sponsoring the drug’s development and testing, voiced concerns about factors “that impacted the commercial return” of PI-88, including the successful joint launch of Nexavar, a competing drug, by the Bayer and Onyx pharmaceutical companies. The company decided that it was not going to make them enough money to become its next billion-dollar blockbuster, so they pulled the plug.

What does this mean? This means that the drug will not be tested and therefore will not be approved and be put on the market. It also means that Chris Parish, who has devised the drug, has lost control of it. He can’t simply go to a different corporation and ask them to fund the research. He doesn’t hold the patent; the corporation does. So the corporation can decide to try again with a different trial, perhaps for a different application. Or the corporation can say, ‘We’re going to cut our losses and we’re not going to sponsor work on this drug anymore.” That means that nobody else can work on the drug. The drug is abandoned..

Junk Food Brings Disease and Economic Growth

The sale of foods that increase disease and the resulting use of medical services to treat that disease result in economic growth, increased employment and elevated stock prices.

This article by Harvard economics and public policy professor Kenneth Rogoff, a former International Monetary Fund chief economist, helps to explain the contradictions. At a minimum, it raises the right questions. It’s very difficult to arrive at the right answers without first asking the right questions.

Can we all agree that something is profoundly wrong with a calculus that judges poor health outcomes to be socially beneficial based on non-holistic economic reasoning that ignores all personal and social costs?

… I want to focus on the food industry’s link to broader problems with contemporary capitalism (which has certainly facilitated the worldwide obesity explosion), and on why the US political system has devoted remarkably little attention to the issue (though First Lady Michelle Obama has made important efforts to raise awareness).

Obesity affects life expectancy in numerous ways, ranging from cardiovascular disease to some types of cancer. Moreover, obesity – certainly in its morbid manifestations – can affect quality of life. The costs are borne not only by the individual, but also by society – directly, through the healthcare system, and indirectly, through lost productivity, for example, and higher transport costs (more jet fuel, larger seats, etc).

But the obesity epidemic hardly looks like a growth killer. Highly processed corn-based food products, with lots of chemical additives, are well known to be a major driver of weight gain, but, from a conventional growth-accounting perspective, they are great stuff. Big agriculture gets paid for growing the corn (often subsidised by the government), and the food processors get paid for adding tonnes of chemicals to create a habit-forming – and thus irresistible – product. Along the way, scientists get paid for finding just the right mix of salt, sugar and chemicals to make the latest instant food maximally addictive; advertisers get paid for peddling it; and, in the end, the healthcare industry makes a fortune treating the disease that inevitably results.

Coronary capitalism is fantastic for the stock market, which includes companies in all of these industries. Highly processed food is also good for jobs, including high-end employment in research, advertising and healthcare.

Interview with Harriet Washington (Part I): Patenting Life and Corporatizing the University

Click here to read the introduction to this four-part interview.

Two events took place in the United States in 1980 that, in retrospect, have dramatically changed the nature and direction of health sciences research. These were the Supreme Court decision in Diamond v. Chakrabarty that allowed the patenting of living things and the passage of the Bayh-Dole Government Patent Policy Act. To begin, could you please give us a broad-brush summary of these policy changes? 

Their import is that Diamond v. Chakrabarty removed the ambiguity about whether one could take out a patent on a product of nature. And specifically for our purposes, whether one is able to take out a patent on a living thing. Living things had occasionally been patented in the past. For example, when adrenalin was patented, there were objections that this was actually a discovery rather than an invention. Even Louis Pasteur faced questions when he patented a strain of yeast. Some said, “You didn’t invent this yeast; you just discovered it.”

So now we have a law that stipulates unambiguously that if something is living, that’s not a bar to its being patented. In addition, we have a second law saying that when a university holds a patent, it is legal for the university to license or sell that patent to a corporate entity. Previously, universities were not allowed to do that, the rationale being that these patents arose from research that was subsidized by the government — that is, by you and me. Our tax dollars paid for the development of these molecules, and the feeling was that a private corporation should not be allowed to profit from it. The 1980 Bayh-Dole Act, supplemented by other laws, changed all that, making it feasible and, in fact, making it desirable for the first time, for researchers to take out patents on living things, based on research performed in universities, and to sell and license them to corporations. Bayh-Dole was basically a golden key for corporations who could now profit from patents that they previously were unable to hold.

A Book Worth Reading: Deadly Monopolies by Harriet Washington

I recently interviewed Harriet Washington, a brilliant scholar and writer whose most recent book is Deadly Monopolies (Doubleday, 2011), a hard-hitting exposé where she insightfully explores several issues certain to have a dramatic impact on the future of healthcare and human freedom.

The interview will be published in the March 2012 issue of Pathways, a Washington, DC, community quarterly, and I’ll be posting it in sections over the next few days on Redwood HealthSpeak.

In this interview, Washington discusses the role of patents, particularly those held by profit-making private corporations on drugs, plants and the human genetic code; the drastic changes over the past generation in relationships between universities and corporations; the erosion of informed consent; and what she calls biocolonialism, including medical research by Western and Japanese corporations in developing nations that abandons the hard-won patient protections available to people in developed nations.

Washington’s earlier book, Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present, won a National Book Critics Circle Award, the 2007 PEN Oakland Award, and the 2007 American Library Association Black Caucus Nonfiction Award. 

She has been a fellow in medical ethics at the Harvard Medical School, a senior research scholar at the National Center for Bioethics at Tuskegee University, a fellow at the Harvard School of Public Health, and the recipient of a John S. Knight Fellowship at Stanford University.