Maine’s Top Court Backs State Authority To Limit Health Plan’s Profits

Among the most important issues facing the American body politic is the extent to which insurance companies and other corporate entitites are allowed to use their financial and political muscle to dominate the delivery of health care. For those who do not believe that corporations should have unlimited powers, yesterday’s Maine Supreme Court decision limiting the premium increases by Anthem Health Plans marks a step in the right direction.

One of the many moving parts of the Patient Protection and Affordable Care Act (aka Obamacare) is the power it grants the Secretary of Health and Human Services to limit unreasonable premium increases by insurers. This Maine decision is based on state rather than federal law, but it tracks well with the issues in play at the federal level:

In a case closely watched by the insurance industry, Maine’s top court Tuesday upheld state regulators’ authority to hold down rate increases sought by Anthem Health Plans of Maine.

In its ruling, the Supreme Judicial Court said that Maine’s insurance superintendent had “properly balanced the competing interests” in arriving at an approved rate increase of 5.2 percent. The insurer, a unit of Wellpoint, the nation’s largest insurer, had sought a 3 percent profit margin as part of an overall 9.2 percent increase in health insurance rates for policies sold to individuals in 2011. It argued that state regulators’ decision to grant a 1 percent profit margin violated state law and the U.S. Constitution by depriving the company of a “fair and reasonable return.”

The Maine Supreme Court is essentially affirming that “reasonable return” is not an area where corporations have the final say. This case, or one like it, may well reach the U.S. Supreme Court. Perhaps one day we will have a Supreme Court that does not consider corporations to be people and remembers that corporations are permitted to exist under law in order to serve a public purpose.

It is not widely appreciated in this country that while many nations allow private companies to provide insurance services, all but the United States limit these to the nonprofit sector. Allowing life-and-death health matters to be influenced by the constant urge to maximize shareholder profits is only permitted here.

That is unlikely to change anytime soon. For now, passing and enforcing laws limiting the more rapacious instincts of corporate CEOs is a necessary step in defense of the public.

FDA Requires Diabetes and Memory Loss Warning Labels for Statin Medications

Pharmaceuticals are a double-edged sword. With help can come harm, as the FDA recognized yesterday in its announcement requiring an addition to the labels of all statin medications of new warnings about increased risk of diabetes and memory loss , which are used to lower cholesterol levels.

Whenever considering use of a medication, there are two key questions. Are the benefits likely to outweigh the risks for a particular individual? And, is there a different method that is safer, more effective or less costly?

The prevention and treatment of heart disease is the main rationale for statins, which are the best selling drugs in history. Is there an alternative approach that is safer, or more effective, or less costly? It happens that there is a method that meets all of these goals — Dean Ornish’s program for reversing heart disease.

Ornish’s methods have been extensively researched over decades, with the results published in journals including The Lancet and the Journal of the American Medical Association, consists of a very low-fat vegetarian diet, exercise (walkign and yoga), and stress management methods including meditation and emotional support groups. In his 1990 landmark article in The Lancet, Ornish and colleagues demonstrated something previusly believed to be impossible — a decrease in plaqueing of the coronary arteries, as measured by quantitative coronary angiography and other scanning methods.

The Ornish program has been covered by insurance policies for many years and was recently approved for coverage by Medicare.

If I am less than enthusiastic about the highly-touted statins, it is because heart disease, with rare exceptions, is both treatable and preventable via the Ornish approach. (I provide a list of references on page 2 of this post.)

Most people are never told by their physicians that heart disease can be prevented through these natural methods, even though the scientific literature shows this to be beyond dispute. Why? First and foremost, I think it’s that contemporary medical practice, so skilled in diagnosis, still has a major blind spot when it comes to non-pharmacologic methods. In other words, the drug option is almost always the first option. And sadly, too often patients are not even told that there is an effective non-drug option.

Part of the problem is that there exists no equivalent of the multi-billion dollar drug company infrastructure to push the lifestyle-based, diet/exercise/stress reduction approach. That is one of the great tragedies of our time.

References after the jump for those wanting to explore the science more deeply …

Walking Back the Decision to Curtail Hormone Replacement Therapy

After waiting several years until the furor died down, it appears that the drug companies and those they fund have decided that the time is ripe to walk back the decision to sharply curtail use of hormone replacement therapy. That decision was based on the landmark 2002 Women’s Health Initiative findings that showed an increased risk of heart disease from HRT, in contrast to previous claims that these medications would decrease heart disease.

See if you can read this article without spotting the not-so-hidden hand of Big Pharma lurking in the shadows. If you arrive at the end of the article without finding it, be sure to read the conflict-of-interest disclosure at the end of the piece.

Menopausal hormone therapy doesn’t have to follow “the lowest dose for the shortest time” strategy for all women anymore, the North American Menopause Society said today.

The group endorsed a flexible approach to duration that takes into account the type and timing of therapy and individual patient characteristics in a statement in its journal, Menopause.

For women in their 50s, the absolute risks are low; younger women without a history of breast cancer can use replacement hormones at least until the normal menopause age around 51, and longer if needed for symptom management, according to the guidelines.

“No ‘one size fits all’ approach is acceptable anymore,” JoAnn E. Manson, MD, DrPH, NCMP, of Harvard, and president of the society, said in answer to a query from ABC News and MedPage Today.

Manson’s position is somewhat surprising since she was a principal investigator for the Women’s Health Initiative, the landmark randomized trial that derailed the hormone therapy movement when it reported a link between Premarin (estrogen/progestin) and increased risk of breast cancer and thromboembolic conditions.

As an organization, “NAMS has close ties with industry, which provides grant support for the organization, advertises in its journal, pays annual dues, etc.,” noted Diana Zuckerman, PhD, president of the D.C.-based National Research Center for Women & Families Cancer Prevention and Treatment Fund.

The new guidelines loosen up on timing, agreed Michelle P. Warren, MD, NCMP, of Columbia Presbyterian Medical Center in New York City, who was also involved with the guidelines.

Women who need hormone therapy can use it for as long as needed, she said in an interview.

That shift should be reassuring for many women, Manson suggested.

After reading the conflict-of-interest disclosures about drug company funding, are you feeling reassured?

Annual Sleeping Pill Death Toll May Top 500,000 in U.S.

All health practitioners have seen patients who develop a dependence on prescription anti-insomnia medications. This apparent increase in mortality risk, however, comes as a surprise.

The usual caveats apply, in that this study does not prove a cause-and-effect relationship. However, the researchers quoted in this MedPage article seem quite concerned.

The use of hypnotic sleep aids was associated with a three- to five-fold higher mortality risk compared with the risk for nonusers, even when the prescription was for a small number of pills, investigators reported.

A prescription for 0.4 to 18 doses per year was associated with a mortality hazard ratio of 3.60 compared with patients who had no prescriptions for hypnotics.

The hazard jumped to 5.32 for patients prescribed more than 132 doses a year, investigators reported online in BMJ Open.

“Rough order-of-magnitude estimates … suggest that in 2010, hypnotics may have been associated with 320,000 to 507,000 excess deaths in the U.S. alone,” Daniel F. Kripke, MD, of the Scripps Clinic in La Jolla, Calif., and co-authors wrote. “From this nonrandomized study, we cannot be certain what portion of the mortality associated with hypnotics may have been attributable to these drugs, but the consistency of our estimates across a spectrum of health and disease suggests that the mortality effect of hypnotics was substantial.”

Patients who used hypnotics most often also had an increased risk of cancer, with an overall cancer increase of 35% among those prescribed high doses.


Scandal Erupts Over Drug Company Relationships with State Medical Boards

Which conflict-of-interest is worse? You be the judge.

1. Drug company money setting the agenda for university drug research, with publication controlled by the corporations, or;

2. Drug company funding the Federation of State Medical Boards to publish a report on the opioid drugs these companies manufacture.

Here’s a powerful piece of investigative journalism on the medical board scandal:

The Federation of State Medical Boards, often develops guidelines that serve as the basis for model policies with the stated goal of improving medical practice — but after its guideline for the use of opioids to treat chronic pain patients was adopted as a model policy, it asked Purdue Pharmaceuticals for $100,000 to help pay for printing and distribution that policy to 700,000 practicing doctors.

That $100,000 was just a small downpayment on the $3.1 million that the Federation’s foundation estimated it would cost for its campaign to get out the word about “safe” use of opioid analgesics in treatment of chronic pain.

The federation, which functions as a trade group representing some 70 allopathic and osteopathic medical boards, won’t say how much money it received from industry, but the $100,000 request was detailed in a document obtained by the Milwaukee Journal Sentinel/MedPage Today from University of Wisconsin School of Medicine and Public Health.

There’s much moreI recommend reading the entire article. And I would expect more to follow.

They say that sunlight is the best disinfectant, but some infections are so toxic that sunlight alone won’t do the job. Legal and/or legislative action seem appropriate here.

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.