Archive for January, 2010

Flu: Epidemic or Shamdemic

Tuesday, January 26th, 2010

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.”

Deals to Keep Drug Prices High

Friday, January 15th, 2010

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.Watch Full Movie Online Streaming Online and Download

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.

Stay-awake Pills

Friday, January 8th, 2010

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?)