We at drugwonks are relentless in the pursuit of more participants and wont rest until we exceed the traffic of insufferable and ego-bloated Huffington blog (amazing what how far one woman can go on her ex-husband’s money and a private jet) . But we do have a perspective…our hits are just beginning to exceed those average daily downloads of this gem: William Shatner’s rendition of Elton John’s “Rocket Man” at the 1978 Science Fiction something or other awards dinner

http://www.youtube.com/watch?v=MVbv6r_tKnE&search=Shatner%20Rocket%20Man

Cut, paste, download and enjoy and tell your friends…about drugwonks of course.

Democrat Congresswoman Rosa DeLauro is making a big stink that her amendment to have the FDA forcibly yank drugs off the market before companies are forced to conduct large randomized studies to establish a safety problem was lifted out of an appropriations bill. Rosa is hypocritical. Here’s Rosa — a cancer survivor — on the vaccine to prevent cervical cancer: âWomen across the country should be encouraged, as I am today, with mounting scientific evidence of the benefits of the HPV vaccine,â said DeLauro. âIt is clear that the science exists to fight a cancer that thousands of women fall victim to each year and there is now significant scientific and medical evidence proving the benefits of the HPV vaccine. With countless public health officials and medical providers agreeing on this medical breakthrough, I am hopeful the FDA will approve this vaccine for use.â

DeLauro, a member of that subcommittee and a cancer survivor, is also the ranking member of the House Appropriations Agriculture Subcommittee with oversight responsibilities of the FDA and its budget. In November, she and over 100 Members of Congress wrote the CDC Advisory Committee on Immunization Practices urging them to make a decision for use based on the advice of medical providers, researchers and public health officials.

As with all products, vaccines will yield safety problems in real world settings and may lead to serious illnesses and some deaths….Yet under Del Lauro’s proposal a vaccine that could wipe out 40percent of the viruses that cause cervical cancer could be yanked forcibly if companies don’t conduct safety studies that get at the source of the the problem….such studies could — because the statistical power and confidence level needed — be ten times the size of the study required to prove the product was effective. And with products As FDA official Scott Gottlieb noted in his blog (fdainsider.com),”The biggest reason why companies are unable to complete post-market studies after drugs are approved through the accelerated pathway, is that all of these drugs treat life-threatening disorders (they have to in order to qualify for accelerated approval) and dying patients are unwilling to roll the dice on a placebo controlled trial â taking a chance they may get little more than a sugar pill â when the drugs are readily available on the market.” Indeed, there are questions if it is ethical to deliberately deny a potentially effective treatment to a patient for study purposes. But Del Lauro would make it a crime not to run such trials.
In fact, there are dozens of studies being conducted independent of the FDA. For instance, Bristol Myers Squibb is working on a drug that is tailored to people whose cancer is Gleevec resistant. There are dozens of studies of genetic tests in development that if used before a drug is taken will help patients avoid well know toxicitieis.
But Del Lauro would suffocate medical progress in order to make a few headlines. She would fine the inventors of innovative medicines for life-threatening illnesses millions of dollars and would deny millions of patients accelerated access to medicines. Her amendment was a death sentence for people like her who live with cancer everyday. Is there anything people won’t do for political gain?

This will drive Drew Altman of the Kaiser Foundation nuts since he belives consumers are too stupid to decide what’s best for them when it comes to health care (has he been paying attention to the Medicare drug benefit?) it should be pointed out that in another step in helping consumers, providers, and payers make more informed healthcare decisions, CMS will be posting information on what Medicare pays for 30 elective inpatient hospital procedures and other common hospital admissions later today. The new information will be posted by CMS at www.cms.hhs.gov. The information takes a snapshot look down to the county level at the amounts paid by Medicare paid for a variety of treatments provided to seniors and people with disabilities in fiscal year 2005. These include procedures such as heart operations and implanting cardiac defibrillators, hip and knee replacements, kidney and urinary tract operations, gallbladder operations and back and neck operations, and common non-surgical admissions.

The information is scheduled to be posted around 2 pm today. A press release will announce the posting of this information.

RE: Follow-on Biologics

Beware putting cart before horse.

And don’t call them generics.

“Indeed, wretched the man whose fame makes his misfortunes famous.”
— Lucius Accius

Bloomberg reports that, according to a sealed transcript of videotaped testimony taken for Vioxx litigation, Dr. David Graham accused FDA officials of working “hand in glove” with Merck to tarnish him.

Are you thinking “visions of grandeur?” Keep reading …

“I experienced threats, intimidation and actually what, in my view, appears to have been a very organized and orchestrated campaign to smear and discredit me,’” said Graham.

Here’s the threat — an important new job.

Graham said former FDA Commissioner Lester Crawford had offered him a promotion nine days before his Senate testimony. Graham said he declined and was surprised by the timing.

“The commissioner is offering me this really high-level job with a lot of responsibility, and then one week later, he’s calling me all sorts of names in an FDA public statement that’s issued on the eve of my Senate testimony,’” Graham said.

Really? I don’t recall any name-calling by Dr. Crawford. And why didn’t Graham accept this “really high level job with a lot of responsibility?”

Why not work to make things better?

Odd? Mysterious? Nope. Just sad.

David, your 15 minutes are up.

Many Canadian Internet pharmacies are quite open about the fact that they’re getting their southern-bound drug supply from the UK. No problem there, right? Na-ah.

The Royal Pharmaceutical Society of Great Britain (RBSGB) and the Medicines and Healthcare products Regulatory Agency (MHRA) have collaborated on new guidance for pharmacists which explains the causes and consequences of counterfeiting and provides pharmacists with practical advice on detecting and reporting suspected counterfeit medicines.

The guidance has been jointly developed by the Royal Pharmaceutical Society of Great Britain and the Medicines and Healthcare products Regulatory Agency following a meeting of the Society’s Practice Committee where the dangers of counterfeit medicines were debated.

Guidance for pharmacists explains the background to counterfeit medicine production and highlights how organised criminal gangs have become involved in the production of illegal medicines and are supplying them through the internet, often to unwitting patients. The guidance offers pharmacists invaluable practical advice on the correct steps to take when they encounter suspected counterfeit medicines. These steps include reporting the situation to the MHRA and ensuring immediate patient safety.

David Pruce, director of Practice and Quality at the RPSGB said, “Counterfeit medicines can be extremely dangerous. They may contain little or no active medicine, a totally different medicine or a toxic chemical. The RPSGB has teamed up with the MHRA to provide invaluable guidance for pharmacists, particularly on how to report instances of counterfeit medicine supply to the MHRA.”

The article by National Enquirer…I mean Philadelphia Inquirer writer Thomas Ginsberg “Donations tie drug firms and nonprofits; Many patient groups reveal few, if any, details on relationships with pharmaceutical donors.” is written like a big expose when in fact it is much ado about old news…. The organizations he writes about have been open about their funding for decades so what’s the big deal? As long as there is transparency — and there is — caveat emptor. Ginsberg tries to draw a nefarious connection between the funding and giving companies a pass on safety…which doesn’t exist. On the contrary, Ginsberg simply swallows whole cloth the assertions of some that ADHD are unsafe and misstates the risk of suicide (it’s suicidal thoughts or behavior)…and wonders why groups that push for access and destigmatization of mental illness wouldn’t spread panic about rare or even non-existent problems. As for transparency….Ginsberg fails to note that the David Oaks of Mindfreedom believes that mental illness has no biological basis and his organization has no problem linkking its website to Scientology funded operations…. I guess taking money from drug companies is worse than forming a coalition of the willing with Scientologists..bad not to disclose one but ok to gloss over the other, right Tommy boy?

In today’s edition of The Wall Street Journal, Scott Hensley reports on the issue of post-market safety studies (and the supposed tardiness thereof) …

… Some in Congress and a recent report by the Government Accountability Office have faulted the FDA for not being demanding or vigilant enough on post-market studies. One solution proposed by some critics would be to give the FDA the authority to order companies to perform such studies, something the agency can’t do routinely under current law.

But even when the FDA does ask for more data or requires additional studies of drugs approved on an express path, companies often don’t follow through, FDA data show. The agency can yank a drug from the market if manufacturers don’t follow through, but that almost never happens.

FDA Deputy Commissioner Scott Gottlieb defended the current approach and reiterated his view that the agency doesn’t need or want unilateral authority to impose such studies on companies. “I think we have the tools we need, but we need to make sure we’re using them effectively,” he said.

Here’s a link to the full article …

http://online.wsj.com/article/SB114894002957165658.html

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.

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

Friday’s Wall Street Journal editorial, “Medicare Bidding War,” left many people confused — me among them — as to how the Journal could be so wrong about something so important — the Part D benefit.

Not surprisingly, the man with the best answer is Mark McClellan. And, as per usual, he addressed the very questions posed by the Wall Streeet Journal even before they were asked. In this case at a May 2nd speech at the American Enterprise Institute.

Here’s a link to his prescient remarks:

http://www.aei.org/events/eventID.1322,filter.all/event-detail.asp

Two years ago CMS stood for “Can McClellan Succeed?”

One year ago it meant “Can McClellan Survive?”

Today it means the future of American health care.

I attended a small lunch yesterday with Dr. McClellan and he made it very clear that now is not the time to take a victory lap. There’s much more yet to be done.

Typical McClellan. That’s why he is the Hardest Working Man in Health Care.

But he did share a few key facts and memorable anecdotes.

Key Fact #1:

The average premium cost is lower than the initial Federal estimate by 30%.

Can you say ” C - O - M - P - E - T - I - T - I - O - N “ ?

Mark also told of the time and shoe leather he and other members of the CMS team spent on the health care hustings. Two stories bear repeating.

The first, according to Dr. McC, happened on a number of occasions. He tells of seniors coming up to him in tears —because they can finally afford the medicines they need.

And Mark, as those of you who know him will attest, is not prone to hyperbole.

The second tells of a woman at a senior center who, after hearing him speak, said that even though she wasn’t currently taking any prescription drugs she was going to sign up because …

“You never know what’s going to happen when you get older.”

To which Mark asked, “How old are you now?”

Her reply, “102.”

With age comes wisdom.