The bi-partisan health care bill passed by the Mass. legislature requires deadbeats who don’t get health insurance only to ask taxpayers to foot the bill of their uncompensated care to the tune of three quarters of billion a year (more than Manny Ramirez makes ) to buy their own insurance. It gives people help to buy insurance on sliding scale according to income. The money comes from the uncompensated care fund most states have to pay for folks to use health care but don’t have or pay for insurance. It expands HSAs, allows consumes and small businesses to purchase health insurance at the same rate as big corporations through association health plans, relies on competition based on price and quality to drive down costs. These are all principles pushed by President Bush.

And by the way, the Mass. bill was applauded by my good friend Ron Pollack of FUSA. Now the question is: if market-based competition is good enough to expand coverage for the 65 and under crowd, why does Godfather Ron oppose the same principles when applied to Medicare?

Here’s a link to a powerpoint presentation of the Mass. plan elements

http://www.hcfama.org/_uploads/documents/live/Conference%20Committee%20House%20PowerPoint.pdf

Lots of discussion today about Governor Mitt Romney’s initiative to provide universal insurance coverage to all residents of Massachusetts. But what’s really unusual is that the debate is over the program rather than politics. The “tease” from Pam Belluck’s article in today’s edition of the New York Times reads, “Combining ideas from across the political spectrum, the state would be the first to require its citizens to have insurance.” And consider this — the bill was passed by a legislature that is 85 percent Democratic and was hammered out with proposals and input from state Democratic legislators; Mr. Romney, a Republican; Senator Edward M. Kennedy, a Democrat; insurers; academics; businesses; hospitals; and advocates for the poor, including religious leaders.

When pigs fly indeed!

Let the debate begin.

I recently had the privilege of discussing the future of drug development with CMPI advisory council member, Joseph A. DiMasi, PhD, Director of Economic Analysis Tufts Center for the Study of Drug Development, Tufts University.

Here are some tidbits you may find of interest —

Q: How will 21st century science help advance the future of drug development?

A: There are hopeful signs that new technologies and analytical approaches will improve the pharmaceutical R&D process in the 21st century. If successful, they will reduce costs and facilitate getting the right drugs to the right people at the right time. There is a growing recognition that genetic and other biomarkers that predict efficacy and toxicity responses or measure disease progression need to be developed, validated, standardized and included in drug development programs. The resulting increase in predictive power can eventually permit smaller and more informative clinical trials. Sharing of blinded clinical outcomes data from failed as well as successful trials across companies can also improve the efficiency of the clinical development process. Bioinformatics, data mining, and Bayesian statistical analysis can also help. Given the high costs of investigating the numerous drugs that eventually fail in testing, advances in discovery and preclinical development technologies that result in a higher hit rate for successful drugs can substantially reduce development costs.

Q: Will these advances impact cost?

A: All of the above technologies and techniques can lower the overall cost of drug development. It is hard to know how much they will do so, but reductions of one-quarter or one-third in average costs seem attainable from increases in success rates or reductions in development times.

Q: What can the FDA do to facilitate these improvements?

A: There is much that the FDA can do, in conjunction with industry, academia, and other government agencies, to modernize the development and regulation of new medicines. These include collaborations to develop and validate biomarkers, facilitating the analysis of pooled data on outcomes across clinical trials, developing guidance on how pharmacogenetic data can be used in labeling, how to utilize outcomes data from post-marketing drug surveillance, where and when it is appropriate to use Bayesian analysis and observational studies, and the evaluation of and standards for electronic medical records submissions.

Sound familiar?

As we’ve discussed before — how about a standing FDA advisory committee on communications issues? See attached article from this week’s Pink Sheet.

Download file

It’s not a “stop-the-presses” moment, in truth it’s kind of a “duh,” but here’s a story that crossed the wires today that speaks to, among other things, the power of the FDA’s bully pulpit.

And here’s to more use of it.

AP — Prescription drug prices soften dramatically even with moderate competition, the Food and Drug Administration said Tuesday in an analysis that shows the arrival in the marketplace of just two generic versions of a brand-name medicine can nearly halve the price consumers pay.

When a brand-name drug faces just one generic competitor, that challenger typically sells for 94 percent of the cost of its branded rival. More competition quickly widens that discount: Once a second generic manufacturer appears, the average price of a generic drug drops to just 52 percent of the brand-name version’s cost per dose, according to the analysis posted on the FDA Web site.

Prices continue to tumble, albeit more slowly but almost without exception, as more manufacturers join the market, the analysis shows. By the time nine manufacturers are producing generic versions of a drug, their products typically sell for just 20 percent of the price of the brand-name medicine, according to the federal analysis of 1999-2004 retail sales data on single—ingredient drug products collected by IMS Health Inc.

Jamie Love, who has written and lobbied obsessively about how pharmaceutical IP is the single barrier to making medicines affordable worldwide threw yet another bomb today from his blog at huffingtonpost.com. This time, in a broadside tamely entitled “Terrorism Pfizer-Style” Love accuses Pfizer of killing Filipinos by suing to block the illegal production of a generic version of Norvasc, Pfizer’s top selling blood pressure drug. http://www.huffingtonpost.com/james-love/terrorism-pfizer-style_b_18290.html?view=print

Norvasc is expensive in the Philippines relative to prices in Pakistan and India for example which have robust — and illegal — generic markets. But the wholesale and retail markup on Norvasc in the Philippines is also nearly 100 percent of the manufacturer price according to the WHO, a fact that Love leaves out in his attack. He also ignores the fact that Pfizer offers a 30 percent discount to people who sign up for their discount plan and does not object to a legitimate licensee making a generic version.

Affordability of medicines is a big problem worldwide. But IP is not the main barrier more often than not. Where it is, companies and countries can come together to work out innovative solutions that protect innovation and limit piracy. Most essential drugs are already generic. Markups, taxes and tariffs matter. And getting medicines to people even when they are free (as inthe case of measles and TB drugs) is often difficult even when the governments are not corrupt or engaged in war. For Love to call Pfizer a terrorist reflects immaturity at the least. At the worst, it reflects a lack of sensitivity to those Filipinos that have been slaughtered by the Abu Sayyaf Group and other militant Islamic groups. Such statements, along with the willingness to ignore all the facts, are yet more reasons to not afford Jamie Love the credibility he constantly craves.

Uwe Reinhardt is the smartest health care policy expert in the history of the world…just ask Reinhardt and he will tell you so in 5000 words or more. It could be that he is confusing the the fact that he is a speed dial holdover of journalists from the Clntoncare debacle (when the Clintonistas disrespected his genuis to the point that he was good for a quote a minute about how stupid Bill, Hllary and Ira Magaziner were) with being the light unto generations, but who am I to argue? His most recent target of contempt is Al Hubbard, the president’s point man on health care who is pushing an effort to make the price of hospital and physician services transparent. It’s a good idea and was never offered as a panacea but since Uwe didn’t come up with it, he is defining it as simplistic and stupid.

But it takes one to know one. If you really want to see what Uwe is really like, get a load of his rant on the Physicians for a National Health Plan web site written back in 2001. He calls Americans weak, selfish, stupid, childish, dupes en rouote to venting his frustration as to why they won’t accept rationing and a government run health plan. It is a rambling, hyper screed. I have posted the entire rant because it reveals the Left’s contempt of the American character and its rapid hatred of anything that smacks of free choice.

http://www.pnhp.org/news/2001/august/uwe_reinhardt_commen.php

As discussed in an earlier blog (Bonjour Amigo, 3/27/06) the issue of an informed and empowered patient is at last gaining traction in Europe. Here are some comments from the panelists:

James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General)

* Part of the problem of course is that information and advertising are not mutually exclusive; legislation cannot decide it, although it has to play a role.

Colin Webb (Patient Advocate Representative on the Enterprise & Industry Directorate General)

* We are in this ludicrous situation in Europe, where anyone is free to give information, quite legally, about pharmaceutical products, except the industry which makes them.

James Copping

* Many points made by Peter Pitts about DTCA are important and we can learn from those lessons. As both Peter and Colin said, the focus has to be on communication. The key issue is to think about how we can go forward.

* The member states have all the power in terms of patient information, but often not the resources needed. One key constituency — the industry — conversely has the resources, but not the power to engage. From the Commission’s perspective, there has to be a balance which allows us to put resources, skills and knowledge to good use without threatening the states’ responsibility for health care and control of health systems and pharmaceutical budgets.

* From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.

* We have an unsustainable mix of regulations, focused very heavily on the statutory information, and the legislation on advertising was largely drafted in the 1980s, before the Internet became a daily feature of many people’s lives. This needs to be addressed in the review.

* The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.

Colin Webb

The entire argument is really not whether information should be given to the wider public; generally people agree to this. The question is: who is going to be the gatekeeper?

For a full transcript of the debate, please visit www.cmpi.org

Just to show that we are not joyless wonkmeister’s who download reports on drug development as a leisure activity, I want to let you know that I was a part-time music critic/reviewer a few years back covering what was know as alternative adult or indie performers. One of the best then — and now — is Jennifer Kimball whose musical versatility and lyrical intelligence makes her hard to categorize and mass market. Thus, despite her charm, humor and talent, she never broke out on an established label. But this is a new day. Digital dowloads and emails are creating microchannels and links to devoted fans that in turn create robust markets for performers like Jennifer and her new recording Oh Hear Us. Jennifer has produced the CD under her own label. The title song is my personal slogan for the new Center for Medicine in the Public Interest. (You can’t bring about change without bringing part of yourself along for the ride. We want to be heard because we believe we have a mission not simply a position. ) You can go to cmpi.org to see what I mean and go to http://www.jenniferkimball.com when you what to be both delighted and moved. Go hear Jennifer, in person if you can.

I debated — or rather tried to debate — Families USA’s Ron Pollack yesterday at a Mercatus Center luncheon briefing for congressional staff on whether to lift the ban on price controls in Medicare. Mercatus usually wants the person proposing change — in this case it was Ron since he wants to impose price controls on Medicare drug purchases - but Ron had asked if I could go first since he wanted a chance to eat his chicken wrap, salad and cookies. No problem, since I had eaten a protein bar beforehand.

I tried getting him to explain why he was for a drug plan that did not include price controls in 2000 and was opposed to the same kind of plan now. It’s okay to change your mind, after all. Though I asked Ron 7 times during our exchange about his flip-flop he never addressed the issue. The same goes for how he can categorize as negotiations a system that requires biotech and drug companies to give the VA a 24 percent discount below wholesale price or lower or be barred from dealing with Medicare, Medicaid and the Public Health Service is a “neogtiation”. Never explained that either. Like a robot programmed to stick to two messages, insulting my intelligence (I had called him a hypocrite in my American Spectator article so I wasn’t expecting compliments ) or trying to con people into believing that a federal law requiring price discounts and no price increases above the CPI is a negotiation, Ron just ignored my questions.

He took issue with a study by Frank Lichtenberg that demonstrated that for every dollar spent on new drugs to treat a medical condition, Medicare and consumers will save nearly 8 by not using more invasive medical procedures. He thought the conclusions absurd though he never read the paper. Here’s my source and a link to the paper itself: “For the Medicare population, average medical expenditure per condition is 57 percent higher ($1,286 versus $817) than for the entire population. Thus the savings from newer drugs are also somewhat higher. The total prescription drug expenditure per medical condition will increase by about $21,but the reduction in total non-drug spending per condition falls $176, yielding a $155 net reduction. Hospital cost reduction accounts for 58 percent of the savings ($102). Home health care is trimmed $37, and office visits $34.” (http://papers.nber.org/papers/w8996)

Typically, he called the Lichtenberg study, which is in a peer-reviewed economics journal, a “Phrma financed study.” I have no idea if it was or not. In any event, he didn’t take kindly to my pointing out that the substance was more important than who financed it just as his receiving funding from currency wrecker George Soros should not divert attention from his basic message.

I don’t think Ron and I will be having lunch again anytime soon.

Per this morning’s press conference (see blog below), an additional point — PhRMA has stepped up to the plate and hit a solid series of singles with their voluntary guiding principles. It’s time for the FDA to step out of the batter’s box and take a few swings.

Remember in the not-too-recent past many blustering elected officials regularly called the threat of counterfeit prescription medicines a “ploy” by the pharmaceutical industry? Well, they ain’t bloviating these days. Consider this frightening piece of news that has just crossed the wire …

DETROIT — The U.S. Attorney’s Office today indicted 18 people it alleged took part in a multimillion-dollar international conspiracy to smuggle cigarettes and counterfeit Viagra to raise money for the Mideast terrorist group Hezbollah.

“The enterprise operated from Lebanon, Canada, Brazil, Paraguay, China, North Carolina, Florida and the Dearborn, Michigan area, perpetrating crimes in the states of Michigan, California, Florida, Georgia, Illinois, North Carolina and West Virginia (and points in between),” the indictment alleges.

Unfortunately this is part of a dangerous global trend. The EU recently went on the record (again) with its concern about the rise of counterfeit drugs in Europe (see 3/28 drugwonks.com blog entry) and Canadian authorities reported that they have made arrests in their on-going “Project Piranha,” seizing a Hell’s Angels gang’s supply of marijuana, hashish — and counterfeit prescription drugs (see 3/25 drugwonks.com blog entry).

When, two years ago, the FDA stated publicly that counterfeit drug schemes were being used to fund global terrorist organizations, certain governors and members of Congress accused the agency of “being in the pocket of Big Pharma.” Well, they are strangely silent today.

And I don’t believe in coincidences.

The New England Journal of Medical Opinion is running an editorial about the Medicare drug benefit by one of the Harvard Medical School’s Repository of Liberal Thinking on Healthcare, Jerry Avorn. The article is entitled “D is for Defective” and can read by going to http://content.nejm.org/cgi/content/full/354/13/1339?query=TOC. And if the article is not enough stimulation, the NEJM has a real treat for you: an audio interview with Dr. Avorn so you can experience his smugness in stereo. I wrote a letter to Avorn challenging him to crawl out of his elite cocoon and debate me on Medicare Part D. Fat chance.

Dear Mr. Avorn:

I read your editorial on the Medicare drug benefit (Part D for Defective) in the NEJM with great amusement. It reminded me of what Mark Twain once said: Get the facts straight and then distort them as you please. Then again, you don’t even get the facts straight.

Perhaps that’s because you rely solely on media accounts of the program design and implementation instead of information readily available about these issues as far back as November of 2004. You would then know as an article in Health Affairs pointed out that the the president “proposed an outpatient prescription drug benefit to be offered under a new voluntary Part D of Medicare … Medicare would pay half the cost of covered drugs The drug benefit would be administered by a [private] pharmacy benefit manager.” To help seniors maintain more generous private-sector coverage, “the president’s proposal had incentives for employers to keep [drug coverage]. Medicare would pay employers 67 percent of the premium subsidy costs it would have incurred if retirees had enrolled in Part D instead.”

This is what you are railing against and you claim that it is a product of “heavy input from pharmaceutical and insurance industries, with predictable results.” In fact, the program described in the Health Affairs article was Bill Clinton’s. It was supported by virtually every Democrat. At the time, President Clinton noted that his program, “competitively selects private benefit manager to deliver the benefit to enrollees in the traditional program,” and instead of “government negotiating directly for prices (price controls) the new benefit has privately-negotiated discounts, gained by pooling beneficiaries’ purchasing power, for all drug expenses.”

Did I miss your _expression of outrage about Medicare chaos at that time?

Note that both the Clinton and Bush plan enrolled all seniors to avoid what is known as adverse selection. That means — though you are a single payer fan and should get the drift — that if the drug benefit was only offered to those without coverage the risk pool would be filled with the sickest and most poor. Enrolling everyone and providing subsidies to encourage employers to retain coverage was a way to spread risk and promote wider participation.

I agree the goal was to enroll those 11 million seniors — including the 7 million that are low income or spend more than $3600 in medicines to enroll. And it seems they are. Nearly 8 million have already, about half of them being those in greatest need and deriving the greatest benefit. By the time May 15 rolls around I will bet you a donut that most of the people that need it will be enrolled. That will be in stark contrast to the dismal record of the state plans you and Ron Pollack said were just as good. Again, since you only seem capable of getting your facts second hand, let me give you information on those state pharmaceuetical assistance programs from the Commonwealth Fund. It found that in 2000, 15 state program enrolled only 19 percent of eligible people, or less than a million. Overall, after a quarter century of operation, the state plans had enrolled an average of 30 percent of all income eligible seniors. No wonder that when it came to shifting Medicaid seniors over to Medicare, states in some instances dropped the ball.

As for the donut hole, you should know that seniors have a choice of choosing plans that fill it completely. Indeed, more than 20 percent have. And then they also can choose to join a managed care plan which eliminates your other concern, that the drug benefit is carved out and handed off to a separate entity that would appear to be only interested in saving the costs of the drug. But you never seem to endorse that. Rather, you call for government controlled, universal drug coverage with technocrats — perhaps using programs developed by you — deciding which drugs to use and which to refuse to administer. And you call for price controls as well. You call them negotiations. But we have seen how negotiations work in the VA, Canada and elsewhere. Name me one system where drug prices are negotiated and the government is the single payer where the government also does not withhold access to medicines or refuse to pay for them regardless of benefit.

In this regard your pretense of scientific objectivity is just that and nothing more. For all of your pompous prattle about evidence based prescribing, your support of government direct negotiating undercuts such an approach. The VA formulary only includes 22 percent of all FDA priority review medicines on its formulary. It excludes Gleevec, Alimta, Humira, Avastin, etc. You blather on about the ALLHAT study when specialists in hypertension community have largely rejected the one size fits all approach you have read into it. Further, in an era of personalized medicine, which you never mention since it does not square with your command and control approach to prescribing, large scale randomized trials are scientifically deficient since they by definition exclude inclusion of any mechanistic understanding of how a drug works or how that mechanism (as a result of genetic polymorphisms) may shape treatment and drug response in subpopulations. Yet, your whole campaign to make drug choices based on safety, efficacy and economic value depends on the creation of a government agency that would fund larger and longer comparative trials that would by definition have no room for the personalization of medical care. So much for allowing doctors to “choose the most appropriate and cost-effective drug…”

I would challenge you to a debate on these issues but I doubt you would give up the intellectual free ride you have been given by your friends in the media. I don’t doubt that you actually believe that you possess some absolute truth about all health matters. And I don’t doubt that many of your allies feel the same way about themselves and that the sentiment, when you are all together, is mutually reinforcing. But that does not constitute reality or even truth. If you ever feel the urge to step outside the circle of hubris to discuss these matters, please let me know.

Sincerely,

Robert M. Goldberg, PhD.
Vice President
Center for Medicine in the Public Interest

Latest release on the FDA website (truncated by me, with the full verbiage at www.fda.gov).

FDA’s Accomplishments in 2005

Innovative Technology

The FDA made progress in implementing its Critical Path initiative, a pioneering project that seeks to apply the best available science to the medical product development process by creating novel tools — such as proven biomarkers and simulation models — for assessment of the safety and effectiveness of drugs and medical devices.

As part of this initiative, the FDA conducted a workshop with The Drug Information Association and The Biotechnology Industry Association to discuss ways of routinely using new imaging techniques in drug development. The agency also created a non-regulatory pathway for discussions with sponsors about certain issues involving submission and use of pharmacogenomic data; concluded an agreement with BG Medicine, a biotechnology research company, to collaborate on discovering signs of liver toxicity in the initial stages of drug development; and published a final guidance on the development of pharmacogenomic data that could help predict the optimum treatment for each individual patient.

Patient and Consumer Protection

The FDA launched several initiatives to reform and make more transparent the system that protects patients from adverse events associated with marketed drugs. The steps taken in 2005 included a contract with the Institute of Medicine to study the effectiveness of the U.S. drug safety system; the appointment of 31 top drug experts to a novel Drug Safety Oversight Board that oversees the management of important drug safety issues; and four contracts to improve FDA’s access to databases that can help identify rare side effects of medicines. Other examples of patient and consumer safety-oriented projects included FDA’s investigation of the mechanical strength of vertebrae following injections with bone glue, the most common treatment for compression fractures that affect a quarter of all women over the age of 50; and studies of the toxicity of acrylamide in food.

FDA made important contributions to the nation’s preparedness for the potential influenza pandemic. The agency provided guidance to speed vaccine manufacturing and availability; sought to increase the number of vaccine manufacturers and their capacity; and addressed such needs as the creation of pandemic strain libraries, for use in vaccine manufacturing and development, and improved assays and testing.

Bioterrorism

To help protect the nation against bioterrorism, Congress has charged the FDA with helping to secure the food supply and encouraging the development and availability of counter-terrorism medical products. As part of this program, the FDA last year strengthened the protection against the effects of inhaled anthrax by approving several generic versions of Cipro (ciprofloxacin). The agency also approved ThyroShield (potassium iodide oral solution) for use in radiation emergencies and developed draft guidance on studies of products to eliminate inhaled, absorbed, or ingested radioactive contaminants.

CFSAN, along with the U.S. Department of Agriculture, the Federal Bureau of Investigation, and the Department of Homeland Security, announced a new collaborative effort with states and private industry to protect the nation’s food supply from terrorist threats through the Strategic Partnership Program Agroterrorism Initiative. CFSAN has spearheaded this effort to identify sector-wide vulnerabilities, mitigation strategies and research needs to protect our nation’s food supply.

Better Manufacturing Practices

Another major FDA priority in 2005 was to ensure the proper manufacture of medications by strengthening compliance with the recently overhauled pharmaceutical standards Good Manufacturing Practices (GMPs). An example of this emphasis has been the agency’s close cooperation with the United Kingdom’s Medicines and Health Products Regulatory Agency (MHRA) in ensuring the correction of sterility failures that had caused the MHRA to suspend the license for Chiron, a major producer of influenza vaccine for the United States.

Both FDA and MHRA provided extensive input on Chiron’s remediation plan for the firm’s facility in Liverpool, and repeatedly inspected its implementation. The joint efforts resulted in the release and delivery of the Fluvirin influenza vaccine to the United States for the 2005-2006 influenza season.

Modernizing FDA

To help protect patients from medication errors, to better inform practitioners about the information they need to use products most safely, and to better enable the use of electronic labeling of drug and biologic products, FDA finalized its new rules governing the format and content of the required information (labeling) that must accompany drug and biologic products when they are marketed in the United States.

Note to Senator Grassley: Please feel free to send a thank-you note to the hard working men and women of the FDA.

“Doctor experienced in bird flu doubts forecast pandemic”
NY Times, March 28, 2006

“U.N. expert says bird flu virus has him “quite scared”
NY Times, March 28. 2006

I guess this is what’s called “balanced” reporting.

No matter how you say it, prescription drug counterfeiting is international health care terrorism

(And so much for certain US politicians who claim that Europe has no problem with counterfeiting.)

EU Says Counterfeit Drugs On The Rise In Europe

BRUSSELS (AP) — An increasing amount of fake drugs is being sold over the Internet in Europe, the European Union warned Monday.The European Commission said a recent survey conducted by E.U. member states, identified 170 fake medicines that were being distributed illegally, mostly through Web sites offering fake or unauthorized lifestyle drugs, growth hormones and sleeping drugs … “I am alarmed at the ever increasing number of counterfeit medicines sold via the Internet. This represents a real danger to the health of patients,” said E.U. Enterprise Commissioner Guenther Verheugen.Lifestyle drugs, such as Viagra, and essential medicines such as antibiotics and insulin are particularly popular with counterfeiters, but there’s also an increasing number of fake contact lenses and even materials such as surgical mesh. Experts warned buying health products over the Internet can be a major health risk.