EasyDiagnosis Second Opinions

According to Dr. Richard J. Ablin, Research Professor of Immunobiology at the University of Arizona College of Medicine in a New York Times Op-Ed article March 10, “Prostate screening is inaccurate and a waste of money.”   Each year 30 million American men undergo testing for  prostate-specific antigen (P.S.A.), a prostate enzyme believed, when elevated, to be a reliable marker for the presence of prostate cancer.  While 16% of men have a lifetime chance of receiving a diagnosis of prostate cancer, they have only 3% chance of dying from the disease. Curious, isn’t it.  The fact is, that infections, over-the-counter drugs like ibuprofen and simple prostatic enlargement occurring in the majority of older men, can all falsely elevate PSA. Moreover, the test detects only a small percentage of cases, and cannot distinguish between the cancers that kill and the vast majority which grow so slowly that 97% of men will die of something else.

As Dr. Ablin points out, the FDA in approving the procedure relied “heavily” on a study showing that testing could detect 3.8% of prostate cancers.  Not a very large figure.  The result over the past several years has been the subjection of hundreds of thousands of men to radical prostate cancer surgery or radiation, resulting in a tragically high percentage of permanent impotence,  incontinence of urine, or both.

Last year the New England Journal of Medicine published the two largest studies of the screening procedure, one in Europe which showed that 48 men would have to be treated to save one life “That’s 47 men who, in all likelihood, can no longer function sexually or stay out of the bathroom for long.”  The American study showed that over a period of 7 to 10 years, screening did not reduce the death rate in men 55 and over.

Dr. Ablin asks why PSA screening is still used, and answers his own question.”Because drug companies continue peddling the tests and advocacy groups push “prostate cancer awareness” by encouraging men to get screened. Increasing numbers of early screening proponents, like Thomas Stamey, a well-know Stanford urologist came out against routine testing, and the American Cancer Society urged more caution in using the test. Certain subsets of patients, e.g. those with a family history of prostate cancer, those patients after treatment with rising levels should be tested, of course.  But this is quite different from subjecting a normal population to widespread screening, something I have discussed in a previous blog, and re-published in my newsletter, Second Opinions, an interview with Dr. Otis Brawley by Maryann Napoli in 2004!

By the way, the good Dr.  Albin who wrote the Op-Ed article from which this blog borrowed freely, invented the PSA test 40 years ago.

Stay tuned.

When researchers, reporters, and others use data to compare two or more different groups, they may present their results in two very different and often confusing ways to emphasize a point of view. These relations may be expressed as either absolute or relative differences. An absolute difference is a subtraction; a relative difference is a ratio.To emphasize how easily people and even most physicians can be fooled, consider the following: Which drug would you rather take, one that reduces your risk of cancer by 50 percent, or another drug that only reduces your risk of cancer from two to one out of 100? Most people would choose the drug that reduces their risk of cancer by 50 percent, but in fact both these numbers refer to the same outcome. They’re just two different ways of looking at the same numbers. Without any qualification, both statements “reduced the risk by 50%” and “reduced the risk by 1 in a hundred” (1%) could be construed as representing either an absolute or relative difference. But note the difference in “feel” between 50% and 1%. Which figure sticks in your mind?

The headlines read, “Tamoxifen Cuts Breast Cancer Risk by 33% in Healthy Women!,” yet it turns out, among all the women in a study who took Tamoxifen, less than 2% got breast cancer, and among those that took the placebo, less than 3% got breast cancer. The real difference was 1%. {”How to Lie With Statistics,” Real Health Breakthroughs, Dr. William Campbell Douglass, 2004}

One of the main studies being cited in support of a drug for advanced breast cancer, Herceptin©, saw 34 deaths in the control group (2.0% of the participants) and 23 deaths (1.4%) in the group treated with Herceptin. According to the authors, this translates into a 46% Relative Reduction in cancer deaths, (wrong calculation; should have been 2.0-1.4 divided by 2.0 or 30%) But the true absolute reduction in deaths is only 0.6% (2.0%-1.4%), almost certainly not statistically significant in this series. Is this a miracle drug? The number, of course, is pure marketing and statistical spin. As reported some time ago in the New Scientist magazine, one of the main cheerleaders for Herceptin is none other than Hortobagyi, a paid consultant of Genentech, who received somewhere between $10,000 and $100,000 from the drug company. He’s one of the proponents who calls Herceptin a “cure.”

Keep in mind that headlines promoting a drug will almost always refer to relative risk, “A breathtaking 40% reduction in risk!” -and this numerical shell game will be copied in the mainstream media, press, medical journals, even the FDA... Pharmaceutical companies, marketing reps, even some physicians anxious to publish and usually supported by commercial drug interests are constantly pushing and exaggerating the supposed benefits of their drugs while minimizing their risks.

The Alliance for Human Research Protection (AHRP) reported last week that the New York State Senate Senate is about to vote on legislation permitting a school nurse of doctor the power to vaccinate children under 18 with the controversial vaccine, Gardasil (and hepatitis B) without parental “consent or knowledge.”Gardasil, a human papilloma virus vaccine, promoted by Merck as an immunization against cervical cancer, is riddled with controversy, and covered extensively in the media, and in my previous blogs.

Dr. Diane Harper, an acknowledged researcher who conducted pre-marketing clinical trials for both Gardasil and GlaxoSmithKline’s Cevarix vaccines, blasted marketing strategies for HPV vaccine, offered the New York State Committee her expert opinion on the vaccines. As Dr. Harper and others have already written, its period of effectiveness is unknown, and evidence shows it poses serious risks for some children and young women such that its risk/benefits are highly debatable.

AHRP has stated the bill, S4779B, violates parental rights to make medical decisions on behalf of their children. If a child is harmed by a vaccine given without consent, and, according to this law, beyond the bounds of school authority, who will bear medical, financial, and Legal authority? In a landmark decision last March, the U.S. Supreme Court ruled that in case of severe injuries or death, federal law does not prevent consumers from suing drug companies in State Court.

But who, if anyone would be entitled to sue the drug company or the State of New York-or both- in cases of misadventure following mandated vaccination of the HPV vaccine?To be noted is Merck’s record of aggressive, illegal marketing of drugs including the Gardasil vaccine.According to the AHRP Newsletter, Merck is on record of having bribed state legislators to support similar bills in Texas. Merck indeed made campaign contributions to the Governor of  Texas to mandate Gardasil. Other states are considering mandating HPV vaccinations. In my opinion, the HPV controversy should be investigated by the FTC, and the FDA if not the Congress.For further information, contact: Vera Hassner Sharav at veracare@ahrp.org

Most patients with susceptible cancers are thankful for chemotherapy and radiation, and are willing to suffer crippling and dangerous side effects, even death, if treatment can help them or prolong their lives. But would you take a drug to treat a bad smoking habit with more warnings than a travel advisory to a war zone, and 90,000 URL’s under its combined search term for “adverse reactions”?

I guess it depends on what you read about Chantix, (Champix in Europe), the trade name for Varenicline, marketed in the U.S. by Pfizer to treat smoking addiction. For starters, the ad for doctor, running for weeks in the JAMA, has almost two pages out of four of “important safety information”- warnings and adverse reactions. Included in the ad are neuropsychiatric symptoms ranging from suicidal and violent behavior, worsening of psychiatric illness, as well as  nausea, sleep disturbance, constipation, vomiting, to which you might add Steven Johnson Sydrome, Erythma Multiforme, and angioedema, etc.

The drug portal, druglib.com  reported an index of adverse events during 2007 alone of 2319 serious events related to ingestion of Chantix from patients and non-professionals Cases resulting in death, 42, life-threatening events, 52, hospitalizations, 306. Because of the findings of a medical watchdog group, the Institute for Safe Medication Practices (ISMP), the drug has been grounded by the FAA for pilots and air traffic controllers. Fearing for the safety of passengers. 150 pilots and 30 ground controllers were ordered to stop taking the drug. The ISMP findings indicate from May 2006 until December 2007 there were 227 reports of suicide attempts, 28 actual suicides, 397 cases of possible psychosis and 52 reports of hostility or aggression. The latter, according to the news report, is what led to the death of popular Dallas musician Carter Albrecht, “…after he flipped out, assaulted his girlfriend and attempted to break into a neighbor’s home before being shot dead.”

A “Black Box Warning(a notice on the packaging of a prescription drug which warns patients and prescribers that the drug has potentially dangerous side effects) was not issued by the FDA until July 2009, 14 months after the FAA issued their edict for pilots and air traffic controllers! I seriously wonder how a drug for smoking addiction can survive the press it’s been receiving for almost three years and why doctors and patients continue to use a drug with this reputation. Will Chantix finally be taken off the market, or will the FDA, as is too often the case, cave in to pressure from Big Pharma, just as the medical profession and the public continue to succumb to drug advertising blitzes?

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.