Lots of stories today about this being the 25th anniversary of the discovery of the AIDS virus and many stories noting how many people are alive today because of protease inhibitors which the last time I checked were developed not by NIH or the Cubans or global health collaborative funded by a global R&D tax but by drug companies. The death rate in the Western world has been slashed by these drugs and the gains to society in terms of increased productvity and deferred health care costs has been substantial. Much of the recent progress has come as a result of efforts to target and personalize therapy. There are now over 60 drugs and vaccines in development. Companies have by and large come around to offer their drugs for free or at cost in those parts of the world where AIDS has hit hardest. And yet the media and activist organiizations have largely ignored this contribution. Case in point was a recent article that started out by claiming that biotech company Gilead was a war profiteer in the battle against AIDS. The last time I checked the Gilead drug was being “sold” if that term can apply for about 27 bucks a bottle ini about 100 countries compared to $800 a bottle in the US. And Doctors without Morals and other HIV activitst groups have the gall to attack Gilead for denying access. And the MSM makes THIS the lead story? Gilead has done more for those dying of HIV with its one drug that than French based group of clinical nomads has done in its decade or so of withdrawing from war torn areas and getting media coverage from Paris for its sanctimony…

Per Dr. Bob’s thoughtful blog (see below), complicated is indeed good for patients. However, “complicated” is bad for two other important constituencies — the media and policy makers. For these folks (with important exceptions) “complicated” is bad because it’s not “simple.” (Sorry, I know that sounds solipsistic, but it’s important to make the point.)

That’s why we (and that’s a collective “we” fellow drugwonks) have to work even harder to make sure those who report and those who decide report and decide based on the facts — as hard as that may be and as naive as it may sound.

The alternative is unacceptable. That’s why it’s called the Critical Path.

The media is abuzz with the news that big drug companies are rolling out drugs that will compete with cancer drugs like Herceptin that target certain pathways or genetic mutations that cause cancer instead of killing the cancer cells themselves. Not exactly. By definition, a targeted medicine does not compete since it hones in on a specific approach or response. Case in point the BMS drug dasatinib which was developed after researchers noticed that a certain subset of patients on Gleevec developed resistance to the drug after a while. Other targeted cancer drugs have the same narrow application at first but then can expand to other uses as the same pathways are implicated in other disease mechanisms…And finally, genetic and protein analysis will determine who are high responders and who are not.

It is getting quite complicated. Better for patients. Which is what matters most. The challenge will be to translate all this into solutions that reduce death and suffering and extending the model to other diseases…

DateLine NBC ran a segment tonight on counterfeit drugs. While this story is nothing new to you drugwonks out there, it’s serving as an overdue wake-up call to tens of millions of Americans. This summer, in collaboration with the Stockholm Network and the Centre for the New Europe, the Center for Medicine in the Public Interest (the home of drugwonks.com) will publish a new book called “Coincidence or Crisis: Prescription Drug Counterfeiting.” It features articles by many leading policy experts, an introduction by Congressman Mark Souder, and is edited by your’s truly.

If you would like additional information on how to order this important new book, please e-mail me at ppitts@cmpi.org.

Not coincidentally, on June 7th I will be testifying in front of the US-China Economic & Security Review Commission on the topic of prescription drug counterfeiting in China. My testimony will begin at 3:30 in room 385, Russell Senate Office Building. Transcripts of the entire hearing will be available at www.uscc.gov

Recess appointment for an important public health official.

I had the privilege to chair an FDA reform task force for the Manhattan Institute, an undertaking Mark McClellan suggested after I invited him to speak at an MI event when I was an MI senior fellow in 2003. I met with two senior FDA officals — Peter Pitts and Scott Gottlieb — that same year about how the report might help to advance the FDA’s fledgling Critical Path initiative. Peter was — like the rest of the FDAers involved in the project — visionary, supportive and courageous in combatting the negativism surrounding the effort. The Task Force we put together was (and is) dedicated, caring and thoughtful, working for free and giving graciously of their time, effort and insights. The result is a biomedical call to arms to apply the insights of drug discovery to the process of drug develpment to make medicine more predictive, preventive and personalized. The agenda surrounding the rollout of the report is below. We hope you can all attend.

AGENDA & REGISTRATION:

CENTER FOR MEDICAL PROGRESS

Prescription for Progress: The Critical Path for
Drug Development
by Robert Goldberg, PhD and Peter Pitts

M Street Hotel
1143 New Hampshire Avenue, N.W.
Washington, D.C.
Thursday, June 8, 2006

Keynote Speaker:

Andrew C. von Eschenbach, M.D.
Acting Commissioner, U.S. Food and Drug Administration

8:30-9:00 AM

Registration

9:00-9:10 AM
Introduction and Overview

Robert Goldberg, Ph.D., Chairman, 21st Century FDA Task Force, Vice President & Co-Founder, Center for Medicine in the Public Interest, Peter Pitts, Director, Center for Medicine in the Public Interest

9:10-10:15AM
Panel 1: Roundtable on Prescription for Progress: The Critical Path to Drug Development

Moderator: Michael Weber, M.D., Professor of Medicine, SUNY Downstate College of Medicine

Panelists:
Jeffrey Cossman, M.D., Chief Scientific Officer, The Critical Path Institute
Gualberto Ruano, M.D., Ph.D., President, Genomas, and Director of Cardiovascular Research, Hartford Hospital
Robert McBurney, Ph.D., Senior Vice President, Research and Development, and Chief Scientific Officer, BG Medicine, Inc,
Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA

10:15-10:30 AM
Break

10:30-11:35 AM
Panel II: The Critical Path Today and Tomorrow: Challenges and Opportunities

Moderator: Steve Usdin, Senior Editor, BioCentury Publications

Panelists:
Janet Woodcock, M.D., Deputy Commissioner for Operations, FDA
Meryl Comer, Patient Advocate for Alzheimer龝 Research
Peter Hotez, Ph.D, M.D., Professor and Chair, Department of Microbiology, Immunology and Tropical Medicine, George Washington University Medical Center

11:35-12:15 PM
Keynote Address

Keynote: Andrew von Eschenbach, M.D., Acting Commissioner, FDA

This from Fiercehealthcare.com: ” A new study by researchers at Kaiser Permanente finds that spending caps on prescription drugs don’t save insurers money and may end up harming the health of patients—especially those who are chronically ill. The research, which appears in the New England Journal of Medicine, followed about 200,000 Kaiser Permanente patients in Northern California who had Medicare+Choice (now referred to as Medicare Advantage). The study found that those with limits were more likely to end up hospitalized and often chose not to pay for their medicines themselves. Researchers like Steve Soumerai at Harvard have essentially been saying the same thing for more than a decade now, but with Medicare in the business of paying for drugs, this type of research may have more impact on benefit design.”

So has our colleague and board member Susan Horn of the Inst. for CLinical Outcomes Research who showed way back in 1996 that formulary restrictions were associated with keeping people sicker and driving up health care costs.

On the one hand we have the WSJ editorial page claiming that there are no cost offsets to a drug benefit and on the other we have the leftists claiming that restrictive drug formularies as a tool for extracting price concessions won’t hurt patients. Yet here is another study showing that caps of any kind compromise health and drive up total spending…. And yet opponents of the drug benefit on either side keep serving up the same stupid argument in an increasingly hysterical form. How did Santayana define fanaticism: It consists of redoubling your effort when you have forgotten your aim. Exactly.

The NEJM article link can be found here:http://content.nejm.org/cgi/content/full/354/22/2349?query=TOC

And speaking of hysterical…get a load of Congresswoman Louise Slaughter’s off-base attack on Part D in the same medical journal. Compare it with the essay by Mark McClellan and Peter Bach. It’s not even worth trying to refute all the lies and inaccuracies except to say that any drug benefit that is cutting costs by massive use of generic drugs is not generating brand drug companes $139 billion in gross profits. That number, a fake factoid drawn up by the urban planner who pretends he is an economist — Alan Sager — was immediately discredited by the people who really know their stuff — the Wall Street analysts who would have issue heavy buy recommendations if gross profits would have increase 50 percent in one year….Yet the MSM and then John Kerry and now Slaughter continue to invoke this number… As it turns out of course, what drug companies that are making money are doing so with new products, many of which are not covered by Part D plans….because they are cancer products.

The two dueling articles can be found here:

http://content.nejm.org/cgi/content/full/354/22/2314?query=TOC

http://content.nejm.org/cgi/content/full/354/22/2312?query=TOC

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.