EasyDiagnosis Second Opinions

The PharmaTimes  reported Jan.4 that the Parliamentary Assembly of the Council of Europe (PACE) is to hold an emergency debate and inquiry into the “influence” exerted by the pharmaceutical industry on the World Health Organization’s (WHO) global H1N1 flu campaign. Was the swine flu epidemic, predicted in many quarters as a”pandemic” a fake from round one? Did WHO cave in to pressure from the drug industry? Nothing new about that-see my newsletter  referring to the 1980’s when the organization expanded its attention to include noncommunicable diseases.Today WHO takes in more than $500 million a year, …money coming primarily from drug companies whose fortunes are intimately connected to its donations.” Along with others, Dr. Paul Rosch in his excellent Newsletter of the American Institute of Stress warned about pandemic flu hysteria early last spring.

The text of the resolution approved by the Assembly calling for the inquiry states that: “In order to promote their patented drugs and vaccines against flu, pharmaceutical companies influenced scientists and official agencies responsible for public health standards to alarm governments worldwide and make them squander tight health resources for inefficient vaccine strategies, and needlessly expose millions of healthy people to the risk of an unknown amount of side-effects of insufficiently tested vaccines.”

The WHO’s “false pandemic” flu campaign is “one of the greatest medicine scandals of the century,” according to Dr Wolfgang Wodarg, chairman of the PACE Health Committee, who introduced the parliamentary motion. “The definition of an alarming pandemic must not be under the influence of drug-sellers,” he added.

Read the rest of this excellent summary by Lynne Taylor  who summarizes how the “false pandemic” campaign began last May in Mexico City when inaccurate or false reporting of normal influenza cases helped WHO “in cooperation with some big pharmaceutical companies redefine 100 or so cases and thus declared them to represent the onset of a threatening new pandemic, although there was little scientific evidence for this.

“These new standards forced politicians in most states to react immediately and sign marketing commitments for additional and new vaccines against swine flu, through ’sealed contracts’ under which orders are secured in advance and governments take almost all responsibility. In this way, the producers of vaccines are sure of enormous gains without having any financial risks.”

Before the end of this month, Jan.2010, an emergency debate was promised to assess the influence of the pharmaceutical industry on WHO. Wodarg announced that 47 parliaments all over Europe are going to be informed, adding that,”Following this, we will initiate an investigation and hearings involving those responsible for the pandemic emergency. The aim is that none of the pharmaceutical companies under any circumstances must be allowed to make their influence felt on pandemic emergencies.”

Federal patent law gives patents owners exclusive rights to exploit their invention for 20 years from the date of first filing. (or 17 years from the date of issue if this occurs before June 1995). We thus assume that generic drug makers can manufacture and market drugs whose patents have expired. This leads to competitive pricing permitting generics, for example like omeprazole, (now over-the-counter) an antiulcer drug, to cost one-tenth the price of Nexium, its chemical equivalent!

But real life doesn’t always work that way. Major pharmaceutical manufacturers have increasingly sought and completed “pay for delay” business deals with generic drug marketers. In these disputed legal arrangements, now being argued in the courts, makers of name-brand drugs directly or indirectly pay generic makers to delay competition by keeping cheaper generics off the market for up to 17 months.

The Congressional Health Care bill already includes such a ban, but the Senate version does not. A group of nine Democrats, led by Herb Kohl of Wisconsin,urged in a letter last month to the majority leader, Harry Reid, that a ban be included in the final legislation.

In recent years deals between name-brand and generic makers have delayed the introduction of a range of generics including cancer drugs, antidepressants, and a whole range of anti-ulcer “prescription-strength drugs,” such as Nexium, the”Purple Pill,” noted above. According to the New York Times the Federal Trade Commission (FTC) has estimated that such deals currently cost American consumers $3.5 billion a year.“These are collusive, price-fixing deals,” said Representative Chris Van Hollen, Democrat of Maryland, “It means the consumer pays a lot more for their pharmaceuticals.” The price differences in fact are sometimes astronomical.

According also, to the New York Times, generics account for only about 22 percent of prescription drug spending in this country, although they represent nearly three-quarters of the prescriptions written, according to the research firm IMS Health. That means 78 percent of the nation’s drug bill goes toward the 22 percent of prescriptions written for name-brand medicines.

Jon Leibowitz, the chairman of the FTC, argues that many settlement deals violate antitrust laws.“These sweetheart deals are being done on the backs of consumers,” Mr. Leibowitz said. “From the perspective of the Federal Trade Commission, these deals are one of the worst abuses across the board in health care and should be stopped.”

For the sake of every American who goes to the pharmacy, let us hope the Senate includes this ban on “pay for delay” in the forthcoming health legislation.

A new disease is defined: “jet lag disorder,” so now, the new drug Nuvigil designed by Cephalon could become the first medicine to be approved by the FDA for combating sleepiness when traveling to distant time zones. Nuvigil is a slight modification of Provigil-sales $1 billion last year-which faces generic competition when the patent runs out in 2012. Both drugs are approved for severe sleepiness associated with narcolepsy, sleep apnea, and -surprise, another new disease, “shift work sleep disorder.” But by prescribing “off label” (unapproved indications by the FDA, but legal), the drugs have been dispensed widely for sleepiness associated with other conditions, or even for healthy people hoping to function on less sleep. That’s permissible for doctors, but promotion of off label use by the manufacturer is not. Cephalon pleaded guilty in 2008 and paid $443 million to settle federal and state charges that it had promoted Provigil and two other drugs for unapproved use.

As also reported in the New York Times, stimulants like coffee and amphetamines are generic, so manufacturers have no incentive to conduct clinical trials. Much better to raise the price of Provigil to $13.60 a pill, 50% more than Nuvigil, and hope for approval for treating jet lag at $9 a pill.*  In a clinical trial in 427 patients flown to France where they never got out of the lab (”food was miserable,” one participant said) showed that those who got the placebo took an average of only 3.4 minutes to fall asleep on the first day. 6.2 minutes, the second day, and 8.2 minutes the third day. Those who got the highest dose of Nuvigil stayed awake for an average of 9.7 minutes the first day, 13.8 minutes the second, and 14.8 minutes, the third day.

It doesn’t look very impressive to me, at $18-$27 for 2-3 days treatment, plus the problem of reported side effects, including headaches, nausea, palpitations, jitters, anxiety, and some problems sleeping on subsequent nights. But maybe the FDA and then the public will go for it.

* The pills will be used only in travelers going East, or “backward” in time zones,-moving their clock ahead, where jet lag is much more of a problem than for those going West or “forward” in time-moving their clock back. (Any comments?)

The FDA has received persistent complaints about outcomes and “quality of life” following LASIK (laser-assisted in situ keratomileusis) eye surgery. Even though the total number of patients reporting problems is relatively low, about 5% one has to keep in mind that reporting rates of complications resulting from a variety of medical causes such as drug reactions, etc. is less than 10%. Even without taking this into account, with 750,000 procedures annually in the U.S. (13.5 million procedures total  performed in the U.S., and only 16.3 million worldwide!) the total number reporting problems amounts to 675,000 patients.

Complaints reported include poor distance vision, dry eye, redness and pain, glare, and halos.  According to the JAMA, Dec. 9, 2009, advocacy groups opposing LASIK surgery have added other complications, including depression and suicide ideation.

See LASIK Surgery watch for discussion of other potential problems with LASIK surgery that are becoming the source of controversy among ophthalmologists. Among these are problems with accuracy of intraocular pressure (IOP) measurements used routinely to screen for glaucoma. “Permanent changes in corneal thickness and biomechanical properties following LASIK result in inaccurate IOP measurement, exposing patients to risk of undiagnosed glaucoma and associated vision loss.” Also mentioned is the problem of measuring the corneal surface in cataract surgery to calculate the power of in intraocular lens implantation.(IOL). Changes to the cornea after LASIK can  cause inaccurate measurement of IOL power, which may result in a poor visual outcome after cataract surgery.

In May of this year the FDA and CDC began reviewing reports of fungal keratitis-a serious infection which can cause destruction of the cornea-  in over 90 patients wearing contact lenses using cleaning/disinfecting solutions, ReNu and MoistreLoc by Bausch and Lomb.

The FDA plans three studies, culminating in a survey of quality of life following LASIK surgery in about 2500 patients from the general population.This may not take place for 1-3 years.  According to this site, LASIK eye Surgery“ is the procedure of choice and can be elected to be done for a person who is dependent on glasses or contact lens for a prolonged period.”  It seems to me that one should consider carefully whether his desire not to wear glasses or contacts supercedes the possible immediate and long-term risks of undergoing surgery on his cornea.

I wonder, in other words, the true percentage of 750,000 patients a year who really Need or benefit from LASIK surgery. See this American Academy of Ophthalmology site.for more information.

Could you afford over $30,000 a month for a newly approved chemotherapy drug? It’s called “Folatyn” an “improved” form of an old drug, Methotrexate; yet no one yet knows if it will prolong life in certain rare cancers. Then why was it approved without evidence of effectiveness? Genzymes’ Clolar for pediatric leukemia costs $68,000 for a required two weeks treatment. As reported in the New York Times GlaxoSmithKline is charging $98,000 for a six-month treatment course for Arzerra, to treat chronic lymphocytic leukemia which strikes 15,000 Americans a year. That adds up to about $1.5 billion a year.

Treating a lung cancer patient with Erbitux, marketed by Eli Lilly and Bristol-Meyers costs $80,000 for an 18 week regimen, and reportedly prolongs survival by only 36 days. In how many patients is that measured, and how are they matched-what are the biases? The Journal of the National Cancer Institute reports that the life of each American who dies of cancer could be extended by one year at the cost of about half a trillion dollars. The authors went on to question the cost benefit analysis of other big sellers such as Avasgin, and Nexavar,” both drugs costing more than $34,000 for a single course of treatment citing poor survival data.”

The authors, quoted in the Wall Street Journal, Tito Fojo and Christine Grady, both of the NIH National Cancer Institute, called for changes in both the testing and and practice of oncology, noting that more than 90% of chemotherapeutic drugs approved for cancer treatment in the past four years in the U.S. cost more than $20,000 for a 12-week course.

They add, the high cost and relatively low benefit of these drugs points to “one of the thorniest questions facing lawmakers working on the overhaul of the U.S. health-care system”: reducing growing health care spending in the last months of patient’s lives. “Some countries, like the United Kingdom, agree to pay for expensive drugs only if they meet a certain threshold of efficacy, but no such rationing exists in the U.S.,” the Journal reports.

Stay tuned.

 

Proposed cuts in Medicare services may well reduce coverage for home health care. Under the bills over 30 million Americans would gain health coverage, but lawmakers have decided that most of the money to cover the uninsured will come out of the present health care system, thus cutting down vital services such as home nursing and health care for the disabled and elderly, amounting to $5.5 or $4.3 billion a year, depending on which bill is passed.  The result will be more hospitalizations-and re-hospitalizations- for patients now being taken care of at home, and an overall increase in Medicare expenditures. This will certainly eat up any savings proposed by the legislators.

Talk about dumb decisions. In order to pay for insuring the uninsured, simply cut down critical expenditures on those already covered.  The old bait and switch.

ALLIANCE FOR HUMAN RESEARCH PROTECTION

 Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org 

Please note that some of the conclusions (value judgments) that were made in the Infomail re: Gardasil, http://www.ahrp.org/cms/content/view/642/9/ should NOT be attributed to Dr. Diane Harper, whose presentation at the International Public Conference on Vaccination, was more nuanced than the Philadelphia Bulletin reported. Dr. Harper presented the following facts:

1. “70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer;”

 2. “There have been no efficacy trials in girls under 15 years.” “There also is not enough evidence gathered on side effects to know that safety is not an issue.”

3. “To date, 15,037 girls have officially reported adverse side effects from Gardasil to the U.S. Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.”

Dr. Harper did not draw conclusions about whether (or not) to vaccinate–except to say, “It is silly to mandate vaccination of 11 to 12 year old girls” given the lack of efficacy and safety data…

The statement: “the incidence of cervical cancer in the U.S. is already so low that “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.” is a quote from a published article by scientists at the National Cancer Institute:

“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all,” said Joan Robinson, Assistant Editor at the Population Research Institute.

Contact: Vera Hassner Sharav veracare

@ahrp.org

212-595-8974

For the past few years the “battle against cancer” includes taking lots of fruits and vegetables-five servings a day-and ingesting vitamins, especially vitamin E and beta carotene, and the mineral selenium. But other measures that are often assumed — and marketed — as ways to prevent cancer are either wrong-headed or nonsensical according to researchers.

The evidence about fruits and vegetables is vague, “far from definitive,” and therefore unproven. Fiber, found in fruits, vegetables and grains, has been touted to prevent colon cancer, even though two large studies found no effect. As for low-fat diets, long advertised to prevent breast cancer, a large federal study randomizing women to a low-fat or normal diet and looking for an effect in breast cancer found nothing.

Then there’s exercise and weight loss, always a good bet to achieve longevity and glowing health. Studies have associated strenuous exercise with less cancer. But that is the same sort of evidence that misled scientists about aspects of diet. “I think it’s wishful thinking,” said Dr. Susan Love, a breast surgeon. “We would like things to be more in our control. I think that’s part of it. And in the absence of anything else, what do we tell women about how to prevent breast cancer? We tell them to exercise and eat a good diet.”

Another study proposed would have been the largest cancer prevention clinical trial ever attempted, involving 35,000 men 50 and older. This time the idea was that vitamin E and selenium might prevent prostate cancer.

The selenium and vitamin E study ended early. Once again, there was no protection from cancer, and there were hints the supplements might be causing cancer. The great hope, after more millions spent on scientific imaginings, again turned into profound disappointment.

Other measures that are often assumed — and marketed — as ways to prevent cancer may not make much difference, researchers say. The key word is “marketed,” or is it “junk science”?

Medical device manufacturers objected strenuously to the recently passed Congressional Health Act which requires them to report sales volumes for a device registry. Neither Senate health bill coming up contains this provision. Unless the House provisions are preserved, researchers will continue to be denied funding to gather critical data. This is the only way to determine the types of patients who would most benefit from a defibrillators, joint replacements, and other devices. Without follow-up on outcomes, medical opinion will remain divided. We still won’t know how products compare with each other how many people really need a specific device, and which patients will be harmed.

Device manufacturers object, of course, to the 2.5% excise tax on medical devices in the House bill, which could generate $20 billion in federal revenues over 10 years. But note that the average profit reported by device makers is over 20% of sales.

Implanted heart defibrillators cost around $25,000 each, but which patients will require or be benefited by having one remains uncertain. In 2004 Government and industry stuck a deal. Medicare agreed to expand the device’s use, nearly doubling the number of patients who qualified for one. The companies, in return, agreed to pay for a study to see which patients really benefited. But the companies reneged, backing out after putting in a measly $4 million, and the Government of the last Administration did not pick up the remaining tab. As a result, researchers still cannot gather data to determine the types of patients who would most benefit from a defibrillator, and doctors keep implanting them in patients who may not benefit at all. Many of these patients may even be harmed, especially if the device has to be removed, a dangerous procedure-something that often occurs, particularly when the batteries ultimately fail. No one even knows whether one producer’s model performs better than a competitor’s.

The problem is not limited to defibrillators or even cardiac stents. Tens of thousands of artificial hips, knees, and now shoulders are implanted every year. Doctors placing these devices have little or no reliable comparative data on which brands last longest or work best in a given patient. According to the McKinsey Global Institute, a consulting group, expenditures on implanted devices stand at about $76 billion annually in this country and are rising at a rate faster than the cost of drugs. (See this excellent article in the New York Times.)

Unlike other hospital products, implants are so-called physician preference items, meaning that doctors — not the hospitals — often choose which manufacturer’s implant to use. Profit margins on medical devices are also among the highest for any medical products, over 20% in the case of a defibrillator or an artificial hip, according to analysts.