Latest Drugwonks' Blog
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.
Robert M. Goldberg, PhD.
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
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.
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.
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.
An excellent article in today’s edition of the Chicago Sun-Times on the strides we are making towards making acute diseases chronic conditions. Here’s a sample:
In the last 25 years, the death rate from heart disease has been cut in half. On another front, the number of cancer deaths recently dropped for the first time in more than 70 years. Yet heart disease and cancer together still kill more Americans than all other causes of deaths combined. Researchers are developing high-tech new treatments such as targeted cancer drugs and stem cell heart therapies.
But the best way to fight the Big Killers is to not get sick in the first place. If we all simply took better care of ourselves, experts say, we could cut the death toll from cancer and heart disease by at least 50 percent.
It’s worth a read. Here’s the link: http://www.suntimes.com/output/health/cst-nws-kill261.htm
Caroline Kovac (IBM’s Princess of Prescience) on what Big Pharma can learn from Big Blue:
“Replace the word blockbuster with mainframe and then we can talk.”
Nope, not a mixed metaphor. I just returned from Brussels where I spoke on what the Europeans call “information to patients” or “ItP” (what we heathens on this side of the Atlantic refer to as “direct to patient communications”). The event was at the Amigo Hotel. (For you trivia buffs, this hotel used to be a prison — and one of its most famous guests was Karl Marx.)
I spoke on the American experience with DTC advertising (both the pros and the problems) and my fellow panelist, James Copping, talked about how the EU is trying to figure out what to do next, since “not American-style drug advertising” is not a go-forward policy. Jim’s a player. He’s the Principal Administrator for the EU’s Enterprise and Industry Directorate-General, the body drafting the EU’s go-forward recommendations.
One interchange between Jim and me that is worth sharing:
COPPING: “We must find new ways to regulate health care information to patients.”
PITTS: “Jim, I think a better way to frame the question is to say that you need to find new ways to facilitate health care information to patients.”
COPPING: “Yes, that’s right.”
God’s speed Mr. Copping.
Here’s an exciting timely and important new paper on what antihypertensives have accomplished and what more could be accomplished if people were treated to guideline. It’s a clarion call to address our nation’s (indeed the globe’s) chronic health care problem — ignoring the urgency of focusing on chronic care.
The Impact of Antihypertensive Drugs on the Number and Risk of Death,
Stroke and Myocardial Infarction in the United States by Genia Long,
David Cutler, Ernst R. Berndt, Jimmy Royer, Andree-Anne Fournier, Alicia
Sasser, Pierre Cremieux #12096 (AG HC)
Estimating the value of medical innovation is a continual challenge.
In this research, we quantify the impact of antihypertensive therapy on U.S. blood pressures, risk and number of heart attacks, strokes, and deaths. We also consider the potential for further improvements.
We estimate the value of innovation using equations relating blood pressure to adverse outcomes from the Framingham Heart Study. Our results show that without antihypertensive therapy, 1999-2000 average blood pressure for the U.S. population age 40 plus would have been 10-13 percent higher. 86,000 excess premature deaths from cardiovascular disease (2001), and 833,000 hospital discharges for stroke and heart attacks (2002) would have occurred. Life expectancy would be 0.5 (men) and 0.4 (women) years lower. At guideline care, there would have been 89,000 fewer premature deaths (2001) and 420,000 fewer hospital discharges for stroke and heart attack (2002) than observed. Our analysis suggests that antihypertensive therapy has had a significant impact on cardiovascular health outcomes but that mortality gains would have been approximately twice as high if guideline care had been achieved for all.
Here’s the link:
New state-by-state fact sheets are now available at the Medicare Rx Education Network website.
Here’s the link: