Friday

Medicare Drug Program-who benefits?

November 6, 2006

This was written after Part D of Medicare was pushed through by the Bush Administration.   It fully applies to the report of Obama's deal with Pharma to get the Affordable Health Care bill approved, as described in a N.Y. Times article of June 8, 2012

Politics of Medicare Drug Program

Those of us who participate in internet dialogue are the small proportion of Medicare recipients who have the requisite skills to research and perhaps comment on this program. The average Medicare recipient is in his/her late seventies, with diminished energy and cognitive capacity. And these are the lucky ones who have escaped chronic somatic or neurological illness.

Instead of providing a program that will ensure that these people receive the benefits of drug coverage efficiently, reliably and economically; instead of building a delivery system around the capacity of the elderly, something quite different, and rather reprehensible has occurred. The elderly Medicare recipient has become the objects of marketing that obfuscates and misleads. Respected organizations such as AARP and trusted public figures offer assurances that gloss over the defects and the social damage of this program.

This Medicare Drug law, or Part D, gives every advantage to the insurer and minimal protection to the consumer. Most of us are aware, and incensed, that the insurer can remove a drug from their formulary with 60 days notice, yet the user, who can no longer get this drug that offers the optimum treatment, may not switch his insurer for up to nine months. But what is less known is that notice of the removal of the drug does not even have to be sent to the client, it merely has to be put on the insurerĂ‚’s web page. How easy would it have been to have required direct notification to the user? But the needs of the users were never central to those who wrote this law.

The increased burden on physicians is an unexamined consequence of Part D. Under this program they will be asked to tailor their prescriptions to the different formularies of various insurers, at the very time that their payment for visits are being reduced by Medicare. And they do not get to bill for their time spent sending requests for exemptions when a drug is not available or discontinued.

Right now there is a growing movement among primary physicians called boutique practice, where they charge an annual retainer of up to several thousand dollars per patient. They still bill Medicare or the private insurer for each visit. The retainer is to get into the door. Dealing with the complexity of Part D will both justify and compel more doctors into this type of practice. It may well result in a two tier system, with the more competent doctors charging an annual fee, and those less skilled treating others who can not afford the retainer.

The supporters of Medicare Part D would like to convince us, and the country, that the grumbling over this program is due to its complexity, that the "“poor dears"” just can'’t quite master such difficult material. When they have it carefully explained to them they will appreciate it.. They would like to convince the country that the doughnut hole will act as a restraint on wasteful spending, as if we really love to take excess drugs and need an impending cutoff of insurance to hold back. They refuse to acknowledge the reality, that when the drugs are no longer reimbursed during the doughnut period many will simply stop taking them, and just get sicker. It is simple to make laws when you ignore realities of the human condition.

Medicare Part D, is predicated on a fantasy, that the sick and elderly will download the daily virus protections, carefully navigate the mine field of phony scams to connect with their insurer on the internet. Mandating this as the exclusive way to monitor continuation of drugs is declaring open season on the elderly for identity theft. And those who complain, watch out! We will be denigrated as wanting socialized medicine, freeloaders who need to have restraint imposed on them.

The administration conveniently wants to impose this restraint by protecting the right of drug companies, their largest contributors, to charge Americans more than any other person in any other country in the world for their products, that are largely developed by basic research that we all pay for. Data is now available showing how costs under this Medicare plan will be much higher than under the VA plan that allows the agency to negotiate with the drug companies. And they will also instill discipline on us by making sure that the insurance companies have absolute discretion to control expenses by cutting off drugs, while we have the right to try to get a doctor to argue with the insurers, on their own time.

For those with low current drug expenses, the sales pitch is protection against catastrophic events, a sickness that requires otherwise unaffordable pharmaceuticals. But even this is illusory. The most expensive drugs are cutting edge, often outside of the mandated categories defined in this program. After years of paying for this insurance there is no certainty or even probability that the most effective life saving drug will be covered. You can hope that the diagnosis comes down during the two months when you can switch insurer, but during the rest of the year you are out of luck.

At what point do we stop trying to decipher this program, comparing one insurer against another using their formularies that they can change at will. When do we realize that the problem is not in our inability to comprehend this plan, but in its intrinsic design.

It is reasonable and right that a limit be put on public funds allocated to the health care of the elderly. We cannot demand that all of the ills that afflict us be treated at any cost. But we have every right to demand a rational program that is accessible to those whose age limits capabilities.

This program that empowers corporations to use every artifice to manipulate the marketing and distribution of life saving products is the logical conclusion of an anti-government, pro-corporate ideology gone mad. It takes the most efficient segment of our medical care establishment and overlays a gratuitous private middleman. And don'’t be fooled, this drug program is not free enterprise; it is a cruel parody of it.

Under Part D, the decision on medication will no longer be between you and your physician, evaluating side effects, cost and efficacy; but will be subject to the vagaries of a private insurer. Their profit, with no limit such as applied to supplementary Medicare insurers, will be the difference between their premiums received and drugs purchased. Their fiduciary duty to their shareholders is to keep the expense of these drugs as low as possible.

Profit maximization for this industry does not come from innovative business models or development of new products, it comes from finding a way to deliver less pharmaceuticals to a very vulnerable population. If the obfuscation and manipulation in the marketing stage is any guideline, the actual delivery of drugs will be a travesty.

This Medicare drug program was passed by the House of Representatives only after the normal half hour vote was extended to three hours, while the Republican leadership threatened and cajoled their party members who were choking on this monstrosity. Input by Democrats, that just may have softened some of the most egregious provisions, were never even considered.

The following is the web site of a study by the Kaiser Foundation that elaborates on the defects of this program:

http://www.kff.org/medicare/upload/Consumer-Protection-Issues-Raised-by-the-Medicare-Prescription-Drug-Improvement-and-Modernization-Act-of-2003.pdf

Read article describing data showing:
Drug Prices in Medicare Plans are 48% Higher Than Veterans' Prices

Thursday

"Significant"-a gateway to confusion


October 4, 2011

Significance

If there is one word that distorts the meaning of scientific research to the public it is the title of this essay, significant. The difficulty lies in it having two meanings, somewhat similar but quite different. The first, which is the most common usage means "important, having or likely to have influence or effect." The second meaning can actually denote something much less, only that if all of the unknown inputs were controlled that the research shows some difference, even if trivial, caused by what the research is exploring.

The first definition, which all but those who have mastered advanced statistics take the word to mean, can never be derived from any given research, as it relates to values; since saying that something is important is a personal conclusion that is made in the context of the larger issue being explored.

It is in the personal interest of every researcher to depict his or her work as being socially important, as meaningful, to be seen as significant in the first usage of the term. Therefore it is understandable that they will describe the results of their research as showing "significant differences", notwithstanding the knowledge that when communicated to the public it will be viewed as meaningful, even though it may not be.

Usually, if one reads the full press release there will be words of caution such as, "these are only preliminary studies and additional work should be done." Yet, the headlines and the reports that go out to the news services do not include these warnings, and use of the word significant by those from prestigious institutions are taken by readers as much more than the technical findings that allowed the work to be published in a peer reviewed journal. This results in the public facing a barrage of news about their most pressing concern, preserving physical and mental health, that seems to be contradictory and inconsistent.

This recent sentence in an article in the N.Y.Times illustrates this problem, "The study showed that women with higher levels of long-term exposure to air pollution had 'significantly' faster declines in cognition than those with less exposure to pollutants." There is no way to know what the quotations around the word significantly meant. Was it an acknowledgement by the editor that this study may not be meaningful, or is it to accentuate the importance of the finding, that we should all be aware of this unreported danger of pollution.

There is a solution to this problem of ambiguity that underlies much of the public's confusion. The word significant must be removed from the lexicon of science reporting at all levels. Any given study that reports any difference in experimental outcome implies that it is statistically significant, and it's very reporting means that it is not random artifact. The degree of certainty of this is expressed in a P,or probability percentage, which could simply be included as (P=.05). This could be left out of mass media articles, but the word significant would no longer be there to confuse the general reader about the particular finding's importance. In journal synopses and discussions of the research, commonly understood words such as "suggestive," "moderate," or "sizable" can allow the researcher to describe the effect to other researchers and to the public.

Elimination of this inherently ambiguous term would not diminish communication in any way. Actually this would be one of the few examples of an effect opposite to what is called "political correctness" which in the name of social benefit usually sacrifices precision of communication. The enterprise of science, which is based on objectivity of research and of accuracy of communication, must enforce a lexicon that advances these goals. Continuing use of a word that only leads to confusion must no longer be accepted by scientists who generate research, or by journalists who translate their efforts to the public.

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Addenda:

This article expresses the issue I cover, where "Clinical Significance" is the first definition, "important" contrasted with "Statistical Significance" which represents the later, or trivial difference in experimental results.  .

Statistical Significance versus Clinical Significance
 http://www.medscape.com/viewarticle/703355_5

A general issue that has arisen in many of the meta-analyses reviewed is the importance of clearly understanding the differences between statistical significance and clinical significance. The ChEIs and memantine have demonstrated statistically significant improvements in outcomes including cognitive and behaviour when compared with placebo, but how do these improvements translate in a clinical setting? A recent review by Hogan [2007] cautioned that many of the reported results from RCTs may be statistically significant but researchers must go a step further to prove that these benefits are clinically relevant. In order to avoid this exaggeration of results, methods including the reporting of effect sizes, NNT, or setting a minimum change in score in order to be labelled a ‘responder' should be considered [Hogan, 2007].

Articles referenced in OpEd Submission:

Air Pollution Linked to Heart and Brain Risks The study showed that women with higher levels of long-term exposure to air pollution had “significantly” faster declines in cognition than those with less exposure to pollutants.

----  How 1-Minute Intervals Can Improve Your Health Despite the small time commitment of this modified HIIT program, after several weeks of practicing it, both the unfit volunteers and the cardiac patients showed significant improvements in their health and fitness. The results, published in a recent review of HIIT-related research, were especially remarkable in the cardiac patients. They showed “significant improvements” in the functioning of their blood vessels and heart, said Maureen MacDonald, an associate professor of kinesiology at McMaster who is leading the ongoing experiment.

Example of Public Relations announcement that benefits from ambiguity of the word.

-------- EnVivo Pharmaceuticals Announces Significant Results from GSM Transgenic Mouse Model for Alzheimer's Disease In its study, EnVivo was able to show that EVP-0015962 significantly reduced the production of total amyloid load as measured by plaque count, surface area and aggregated AB in the brains of transgenic mice after 12 months of daily oral administration.

A Bill now in the house committee on government affairs, The Research Works Act H.R.3699, would further limit public dissemination of research that is funded by public funds.  A separate essay on this is being written.  This is a summary

http://openaccess.eprints.org/index.php?/archives/867-guid.html
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From Journal American Scientist

Do We Really Need the S-word?

The use of “significance” in reporting statistical results is fraught with problems—but they could be solved with a simple change in practice

Megan D. Higgs