Latest Drugwonks' Blog

According to the Financial Times, the WHO will “….start talks on a global plan of action for research on priority health needs in developing countries. The WHO will hope to encourage development of medicines neglected by private industry.

The WHOâs 192 member states approved a consensus resolution on Saturday establishing an intergovernmental working party to come up with a strategy and action plan within two years…..

The Calling the move a âbreakthroughâ, Médecins Sans Frontières, the medical humanitarian group, said it would ensure that patientsâ needs rather than profits drove innovation.

The WHO accord followed what health officials called a âmiraculousâ change of tack by the US, which had previously indicated strong opposition to any steps that might imply a weakening or sidestepping of the drug patenting system.

In return, developing countries led by Brazil and Kenya dropped demands for a binding research and development framework and explicit support for âopen accessâ and other models of promoting health research outside the patent system.

The global strategy will implement the recommendations of a report to the WHO last month by an independent commission..”

Translation: Jamie Love’s effort to impose a Soviet style R&D planning bureau funded by a global tas on countries has been destroyed. The framework for the future will be the report of the Commission on Intellectual Property and Public Health which has no mention of Jamie Love and his beloved R&D treaty….

His approach would have suffocated and stifled efforts to transfer technology to produce vaccines and drugs to developing countries and mired efforts to innovate in politics and bureaucratic infighting. I believe the current patent system is not suited to promoting the development of drugs for neglected disease just as it was not suited to promoting orphan drug development 25 years ago…..and we need to come up with a way to shift production and pricing to developing countries more quickly….but the Stalinist model promoted by Love would make it impossible…thank goodness the WHO is moving in a dramatically different direction, which including rejecting the R&D treaty.

Why do policymakers and the media continue to lump side deals to stall generic competition with the introduction of generic versions of medicines by the companies that developed the drugs in the first place. They are entirely different animals with different results. One action prevents consumers from obtaining generic medicines in a timely fashion. The latter action introduces a generic drug at a launch price cheaper than that introduced by a generic drug company with a 180 day market monopoly. Some generic firms are complaining that compettion from authorized generics are cutting into their profits. How about that.. the so-called authorized generic adds competition to the generic marketplace and drives down prices. Let’s remember that the name of the law that brought the generic industry into being is the Drug Price Competition & Patent Term Restoration Act not the Generic Drug Company Guaranteed Profit Act. What’s better for consumers in the long run? Studies by Ernst Berndt show that in the long run there is more generic competition and lower prices for consumers with authorized generics. When the media and generic drug lobbyists conflate suspicious stalling tactics with legal and consumer friendly market actions, neither the truth or the public health is served

By Tony Pugh
Knight Ridder Newspapers

WASHINGTON — The Medicare prescription drug benefit has been cursed for its failures and celebrated for its triumphs.

The program’s flaws and shortcomings were exposed early and often in the first few months after its January launch. However, recent news of lower-than-expected drug costs, patient satisfaction and a seemingly successful enrollment drive have given the program a new bounce that could help Republicans fend off future Democratic attacks.

The cost of the drug benefit has declined from a projected $737 billion over 10 years to $675 billion. Beneficiary premiums are averaging $25 a month, down from $37 in last July’s budget estimates. And the projected net cost to taxpayers for 2006 will be $30.5 billion, 20 percent less than an earlier estimate of $38.1 billion.

Here’s a link to the whole article …

http://www.miami.com/mld/miamiherald/news/nation/14667904.htm

Interesting that Sid Wolfe and Public Citizen oppose user fees on the grounds and wants the government pay for all clinical trial and drug application review work to insure objectivity but has no problem charging people for info on its “Worst Pills, Best Pills” website or for the book by the same name as part of it’s noble effort to keep people from unsafe and deadly drugs. You would think such a high-minded group dedicated to such humane purpose would make the website and book a freebie….or hand the project over to the FDA free of charge. It would make the scaremongering garbage any more reliable but at least it would make the increasingly irrelevant and repetitive Sid Vicious consistent for change.

Suzanne Sataline’s article “ADHD Study May Renew Debate” does a disservice to parents and patients everywhere dealing with ADHD by doing a poor job of placing the relative risks and benefits of medication for the illness in proper context. The study you cite fails to distinguish, for example, between different medications and between extended and regular release medications. Randomized clinical trials show that patients taking extended release stimulants are less likely to the ER than those using three times a daily formulations. Then too, the study ignores the fact that children with ADHD are more likely to use the ER than children without. Most troubling, you ignore the fact the the incidence of adverse events with such medications is extremely low compared to other widely used medications. For example, aspirin and other painkillers are associated with 117,000 hospitalizations and thousands of deaths each year. By comparison children diagnosed with ADHD are no more likely to be sent to the ER than children without the illness, a point your article fails to make. Ultimately Sataline’s article — and the study upon which it was based — was structured to scare, not inform.


“Based on what you know or have heard …”

58% of people in a new Wall Street Journal Online/Harris Interactive health-care poll (conducted online May 12-16) said that, “based on what you know or have heard,” the FDA does a fair or poor job ensuring the safety and efficacy of new prescription drugs, while 36% said the agency does a good or excellent job.

Based on what you know or have heard.

Two years ago, the numbers were reversed: then, 56% felt the FDA did a good or excellent job in the ensuring safety and efficacy of new prescription drugs, while 37% felt the agency did a fair or poor job in this regard.

Based on what you know or have heard.

Of 2,371 adults surveyed in the latest poll, 80% said they are somewhat or very concerned about the agency’s ability to make independent decisions that will ensure patients have access to safe and effective medicines.

Based on what you know or have heard.

The poll found that 82% feel the FDA’s decisions are influenced to some extent or a great extent by politics rather than medical science.

Based on what you know …

Most Americans don’t know the most basic things about what FDA is and what it does. And ignorance rarely evokes bliss. Most Americans think the FDA invents as well as regulates pharmaceuticals.

Or have heard …

What most Americans have heard over the past two years are false accusations, slanted half-truths, self-serving pronouncements, ad hominem attacks, vicious slander, and destructive score settling.

This is what some of our elected public officials hath wrought. And what have these same individuals done to improve matters?

(Pause for reflection)

I can’t think of anything either.

As George Bernard Shaw wrote,

“When a stupid man is doing something he is ashamed of, he always declares that it is his duty.”

For shame. And you know who you are.

According to Robert Pear “Democrats said they were counting on the doughnut hole to revive public criticism of the Medicare drug benefit, which has died down since March, when many of the initial problems were straightened out.”

“… Nancy Pelosi of California, has urged Democrats to hold town meetings and other events to keep up the drumbeat against the program, which she has decried as this disastrous Republican Medicare drug plan.”

The truth? Can Nancy Pelosi handle the truth?

FDA Releases Medical Device Innovation Initiative

It’s about time.

According to the FDA website, “… The Center for Devices and Radiological Health (CDRH) is taking new steps to expand its current efforts to foster the development of safe and effective medical devices through a variety of initiatives and regulatory process improvements … This initiative includes the following efforts:

* Promoting scientific innovation in product development (Provide Regulatory Clarity Through Guidance Development, Invest in the Critical Path, Conduct Stakeholder Outreach and Improving Communications);

* Focusing device research on cutting edge science (Laboratory Research to Support Efforts to Improve the Device Development Process);

* Modernizing review of innovative devices (Implement a Quality Review Program, Provide Clarity Through Guidance Development, Leverage Information Technology Solutions, Expand Clinical and Scientific Expertise at FDA)”

A link to the full statement can be found at www.fda.gov.

Stephanie Saul has found the formula to make the front page of the NY Times: write article about the Rx industry that depict their products as unsafe or demonstrate an unholy link between clinical guidelines and industry support. Oh, and ignore the facts when you have to in order to keep the story line in shape. The most recent example of Stephanie’s shameless stylistics is today’s article entitled, “Unease on Industry’s Role in Hypertension Debate ” which starts out by noting that drug companies paid $700k ” to a medical society that used most of the money on a series of dinner lectures last year to brief doctors on the latest news about high blood pressure…. The same three companies â Merck, Novartis and Sankyo â also gave the money that the medical society used to formulate the main talking point of those briefings, an expanded concept of high blood pressure that many doctors say would increase the number of people taking drugs. …”

Let’s get one thing straight first. Most people with hypertension don’t take drugs and those that do fail to take them regularly or appropriately. So is it a bad thing to increase the numbe rof people taking drugs given the fact that high blood pressure is the leading cause of strokes and heart attack in the world and taking such drugs will cut strokes 35 to 40 percent and heart attacks 20 to 25 percent?

Now what Stephanie is talking about is something call pre-hypertension. No one seems to quibble about treating pre-cancer though fewer people die from cancer than heart disease but no matter. Or that from both a mechanistic and epidemiological level is pretty flat out certain that both elevation of blood pressure and lipid levels begin early in life, even in childhood in some people. Didn’t read that in Stephanie’s screed? What a suprise. High blood pressure was listed as a primary or contributing cause of death in about 277,000 American deaths in the year 2003. About 69 percent of people who have a first heart attack, 77 percent of those who have a first stroke, and 74 percent of patients with heart failure have blood pressure higher than 140/90 mmHg. Since blood pressure rises rapdily the idea is to prevent the exponential rise by getting to people who are on the cusp before it does as a way to stop hypertension before it starts. On the number of people on the cusp — prehypertenion — have been rising rapidly as well. So researchers wanted to see if you could slow the progression to hypertension by giving folks on the cusp blood pressure drugs. It did.

But all Stephanie could see was that Astra Zeneca paid for the study, not the potential public health beneifits of lowering blood pressure earlier than ever or the the fact that efforts to do so through diet and exercise alone have been a miserable failure. Obesity epidemic anyone?

Also, she left out some interesting facts. That the two “heroes” of her piece, Steve Nissen and Jean Sealey, have problems of their own. Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, as followers of this blog know, abused his position as a FDA media talking head and FDA advisory committee member along with another malcontent on Stephanie’s speed dial, Curt Furberg, MD to recommend a black box warning on drugs for ADHD in order to slow what he characterized as the âout of control growthâ use of the drugs.
Meanwhile Stephanie depicts Sealey leaving the professional association of hypertension specialists as a principled decision and a outgrowth over a battle about Rx influence. In fact, Sealey was on the verge of being forced to resign for reasons that are being investigated by the New York State Attorney General. Amazing how that never made it into the New York Times. It’s enough to give you pre-high blood pressure.

The Zipless Blog

  • 05.22.2006

Does Pharma suffer from Fear of Blogging? Of course. And with good reason. If you would like more information on this topic, may I recommend a new report by HCPro. It’s not out until June … but that’s, well, next week. It features interviews with various experts including the wonderfully bright Coleen Klasmeier and me.

The HCPro web address is www.hcpro.com

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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