Patents and Generic Drugs

President Obama is addressing the issue of moving generic drugs more quickly to market. Big PHARMA has had it’s way for the last 60 years with cost increases for medications far above the inflation rate. We now have drugs, single medications, that cost more than automobiles and over a lifetime more than the average home. Imagine, a single drug being the most expensive purchase of a lifetime. That’s the unsustainable monster we’ve created. More here from the Washington Monthly.

A medicynical approach would be to have market based patent durations. If priced reasonably a full patent would be awarded, if priced excessively the length of patent would be proportionally reduced. The devil, of course, is in the details.

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Prevent Cancer by behaving well

This article from the BBC may somewhat overstate the case but exercise, diet and weight control are not only good for your mental health but for your physical health.

“about a third of the 12 most common cancers in high-income countries and about a quarter in lower income countries could be prevented through diet, exercise and weight control.”

Estimated percentage of cancers that could be prevented

US UK Brazil China
Mouth, pharynx & larynx 63 67 63 44
Oesophagus 69 75 60 44
Lung 36 33 36 38
Stomach 47 45 41 33
Pancreas 39 41 34 14
Gallbladder 21 16 10 6
Bowel 45 43 37 17
Liver 15 17 6 6
Breast 38 42 28 20
Endometrium (womb) 70 56 52 34
Prostate 11 20 n/a n/a
Kidney 24 19 13 8
12 cancers combined 34 39 30 27
All cancers 24 26 19 20

Medicynical note: No prospective study of this is possible and no one knows how early one must start behaving to have a salutary effect on cancer prevention or life expectancy. One can take solace in the fact that following the recommendations should make you feel good, even if it may not have the ultimate beneficial effect.

It shoul
d be noted that the outcome benefit is not dependent on use of supplements, omega 3 oils, and other unproven remedies.

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An 11 year old murderer? TOO MANY GUNS

Another child murderer. An instant of misjudgment and this youngster took the life of his father’s pregnant fiance, ruined his own life and that of his father.

Is this what the founders had in mine with the second amendment? Guns are too prevalent. We need some regulation here too.

Addendum: 2/26 Adding insult to the injury of our ridiculous gun laws, is how we imprison child killers. Imagine having this problem in the first place. We facilitate murder by having guns so available and their use so commonplace.

“Pennsylvania has charged Jordan with two counts of first-degree murder in the February 20 shooting, and placed the fifth grader behind bars. Jordan’s new home is the Lawrence County jail’s 8-by-10 suicide-watch cell.”

“Should Brown receive the maximum penalty, he would join a select fraternity, one that includes Eric Smith, who killed a 4-year-old friend when he was 13, and is now serving a sentence of 9-years-to-life in upstate New York. And Joshua Phillips, sentenced to life without parole at the age of 14 for killing his 8-year-old neighbor in 1998. Phillips began serving his sentence when he was 15 in the prison’s “general population,” sharing an open dorm with dozens of adult men”

Medicynical Note: This says more about our culture and values than the excessive verbiage and pontification of the right.

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Legislative License to Practice?

I don’t understand how state lawmakers have the license to legislate the use of specific tests and in some cases procedures, without a consensus from the medical community. Yet that’s what’s happening in the Washington State legislature where a requirement that patients in hospitals be screened for resistant staphylococcus is currently being considered, over the objections of the medical community.

Indiscriminate testing is a slippery slope. For example, should we also test all people in nursing homes? How about periodic screening of all health care providers? Caregivers? Visitors? Where does this lead?

Does mandated testing have a role when when the “epidemic” of staph in our hospitals, in Washington State, appears to be coming under control with the incidence of the disease dramatically declining. Should we accept legislative grandstanding that mandates testing and likely expensive expenditures? Or should we consult with and trust our best clinicians and accept their recommendations?

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Comparison Studies in Medicine

Our current pharmaceutical company financed research system is an elegantly designed facade that elevates drug marketing over science. It is a fact that more is spent on marketing than research. Big PHARMA finances “safe” studies that often don’t compare results with the best available alternatives–often much less expensive. Afterall why take the chance that a new and very expensive medication/advance is not better?

It’s hard to believe that we needed legislation for this.

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Et tu Multivitamins–They don’t work either

A large study of women taking vitamins showed no efficacy in preventing cancer or heart disease.

“But the largest study ever conducted in post-menopausal women has found “convincing evidence” that multivitamin use has “little or no influence” on the risk of common cancers, cardiovascular disease or dying from any cause in post-menopausal women.”

“The research involved 161,808 American women, age 50 to 79, who are part of the ongoing Women’s Health Initiative, the largest study of women’s health. A total of 41.5 per cent of the women used multivitamins. The most popular was a multivitamin with minerals.”

“The women were enrolled in the trial between 1993 and 1998. After an average eight years of followup, researchers found no evidence multivitamins either increased or decreased the risk of cancers of the breast (invasive), colon/rectum, endometrium, ovary, kidney, bladder, stomach or lung.”

“They also found no significant effect on the risk of heart attack, stroke and blood clots in the veins.”

What can a person concerned about his/her health do to prevent disease and expect that it will work? At this point the proven interventions are:

1. Eat a well balanced diet. Vitamins appear to be more effective if taken in the form of a healthy diet.

2. Exercise and control your weight.

3. And probably most important, don’t smoke.

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A Corrupt System of Care

This, in the Wall Street Journal, describes the reality of the uninsured and under-insured. Guess who will ultimately pay?

“Hospitals are adopting a policy to improve their finances: making medical care contingent on upfront payments.”

“The bad debt is driven by a larger number of Americans who are uninsured or who don’t have enough insurance to cover medical costs if catastrophe strikes. Even among those with adequate insurance, deductibles and co-payments are growing so big that insured patients also have trouble paying hospitals.”

“Asking patients to pay after they’ve received treatment is “like asking someone to pay for the car after they’ve driven off the lot,” says John Tietjen, vice president for patient financial services at M.D. Anderson. “The time that the patient is most receptive is before the care is delivered.”

Medicynical note: For these patients with cancer it is pay or die. One can only speculate on what happens to those who can’t pay. Is this what we, as a society, desire?

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Litigate to delay

Pay to delay is strategy of pharmaceutical companies whereby the owners of a drug patent pay (bribe?) generic manufactureres to not market generic competition for their patented agent.

“lucrative settlements between generic and branded drugmakers have flourished. According to the FTC, nearly half of all settlements between 2006 and 2007 involved payments to keep low-cost drugs off the market.”

Imagine, our non-system facilitates keeping drug costs high. What a system.

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Mark Dybul’s Removal–inevitable

Mark Dybul by all indications was as effective as an HIV/AIDS coordinator could be working for a narrow minded, religious right agenda driven administration. That being said it appears he compromised too often to be held over in the new administration.

This from Michelle Goldberg in the American Prospect:

“A gay man who had, in the past, donated to Democrats, Dybul seemed to pride himself on his ability to make common cause with conservatives. As global AIDS coordinator in the Bush White House, he often sided with allies like Rick Warren rather than with women’s-health advocates on issues ranging from abstinence to sex-worker outreach to family-planning funding.”

“Thus, while PEPFAR did miraculous things to treat and care for people with HIV — an expensive but relatively uncontroversial undertaking — it missed many opportunities to prevent new infections. Initially, at the administration’s behest, the legislation authorizing PEPFAR earmarked a third of the money dedicated to HIV prevention for abstinence and faithfulness programs, often run by religious groups. With other PEPFAR prevention funds directed toward things like mother-to-child transmission, very little was left over for comprehensive sex education and condom distribution. In fact, in order to fulfill the abstinence earmark, Dybul’s office told those in the field to devote a full two-thirds of the money available for the prevention of sexual transmission of HIV to programs encouraging chastity and fidelity.”

Medicynical note: An effective proponent of ineffective prevention policy is not an automatic reappointment candidate. As noted the abstinence mandate in the Bush/Dybul program corroded the effectiveness of the interventions. Dybul appears to have compromised what might work with the ineffective and scientifically flawed.

I’ve always felt that selling out the AIDS program to the religious right, who previously couldn’t even say the AIDS word, was a travesty. In that Dybul facilitated this sell out he didn’t deserve reappointment.

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Corrupt Practices vs Corruption–Conflicts of Interest

Marcia Angell during and after her tenure as editor of the New England Journal of Medicine has decried pharmaceutical industry practices. Her recent review of three books in the NY Review of books has gotten the attention of industry.

The books were Side Effects: A Prosecutor, a Whistleblower and a Best Selling Antidepressant on trial by Alison Bass, Our Daily Meds: How the Pharmaceutical Companies Transformed themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs by Melody Petersen, and Shyness: How Normal Behavior became a Sickness by Christopher Lee.

In the article Angell highlighted the practice of having researchers on payrolls of companies whose products they were evaluating. She called the practice corrupt and urged:

“But there is clearly also a need for the medical profession to wean itself from industry money almost entirely. Although industry-academic collaboration can make important scientific contributions, it is usually in carrying out basic research, not clinical trials, and even here, it is arguable whether it necessitates the personal enrichment of investigators. Members of medical school faculties who conduct clinical trials should not accept any payments from drug companies except research support, and that support should have no strings attached, including control by drug companies over the design, interpretation, and publication of research results.”

Dr. Alvin Shatzberg and his University (Stanford) took issue with calling conflicts of interest a corrupt practice and had an exchange of correspondence with Dr. Angell in the February 26, 2009 issue of NY Review of Books. The major point of Dr. Shatzberg and the University appears to be:

“The exchange of money or other items of value between the medical community and medically related industries should be transparent and limited to payment for legitimate services.”

“As Angell notes, the provision of money and other valuables by pharmaceutical companies to medical schools, medical societies, and individual physicians has been widely accepted for many years. Some of the effects, such as the development of effective new treatments, have been positive. It is good that society and the profession are finally paying attention to the consequences that are negative. But standards-of diagnosis, research, and behavior-change over time. It is unfair to suggest physicians are “corrupt” for activities that were virtually universal when they occurred.”

Dr. Angell replied:

“My article was about the conflicts of interest that permeate medicine, not failures to disclose them. And nowhere did I state or imply that they were unlawful, as Schatzberg’s lawyer charges. My point was that pervasive conflicts of interest corrupt the medical profession, not in a criminal sense, but in the sense of undermining the impartiality that is essential both to medical research and clinical practice.”

Medicynical note: It’s necessary to read the original article to fully appreciate the issues. Medicine in my professional lifetime has compromised itself. Our profession no longer can be relied upon to put the patient’s interest first. We’ve monetarized the system and the choices made have corrupted it.

I’ve always felt that disclosure of a conflict of interest did not help. For example, what does it mean when the author of an article reveals he/she is being paid by and/or has a financial interest in the company whose drug, procedure, or medical device the doctor is evaluating. How much should we rely on the conclusions of an obviously biased source? The practice at best opens the door to doubt and at worst corrupts and irreversibly contaminates them.

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