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CBO Estimate of the Statutory Pay-As-You-Go Effects for an Amendment in the Nature of a Substitute to H.R. 5651, the Food and Drug Administration Reform Act of 2012, as posted on the Web site of the Committee on Energy and Commerce on May 25, 2012
Source: Congressional Budget Office.
The bill would modify how the Food and Drug Administration regulates drugs and devices in a broad range of areas. Several provisions of the bill would affect when lower-priced drugs enter the market. Changing the timing of availability of lower-priced drugs affects spending in federal health programs that pay for prescription drugs and biological products. It would also affect the costs of health insurance plans and thus federal subsidies for health insurance purchased through an exchange. On net, the bill would result in a reduction in the deficit of $114 million over the 2012-2017 period, which is the sum of a reduction in direct spending of $113 million and an increase in revenues of $1 million. Similarly, the 10-year net reduction in deficits of $370 million is the sum of a reduction in direct spending of $365 million and an increase in revenues of $5 million.
The CBO chart can be found here.
The mayor will issue a proclamation in honor of the day established by the Salvation Army in 1938 to honor donut lassies who served treats to soldiers in WWI.
Mayor Bloomberg has stirred up controversy by saying he wants to ban the sale of sugary drinks over 16 ounces from establishments that receive a letter grade from the Health Department.
The health commissioner says the ban could make an immediate impact.
"Sugary drinks are not the entire obesity epidemic but they are uniquely strongly associated with the rise in obesity over the last 30 years. There's something about this sugar water product which leads to long term weight gain," said City Health Commissioner Thomas Farley.
The New York City Beverage Association and fast food restaurants are among those sharply criticizing the plan, with a spokesperson for McDonald's calling it "misguided."
The Riverdale Press
May 30, 2012
By Peter J. Pitts
The second anniversary of President Obama’s Affordable Care Act (ACA) just passed. And two years after its enactment, the debate over health care reform is every bit as contentious. The recently released forecast from the Congressional Budget Office (CBO) offers fodder to both sides.
On one hand, the law may cost $50 billion less over the next ten years than projected in January — but the national budget deficit is now projected to be $93 billion higher. Medicare and Medicaid expenditures are projected to more than double over the next decade, despite 4 million fewer Americans getting health insurance.
For anyone in favor of improving our healthcare system, these numbers make clear just how desperately our county’s entitlement programs need real reform.
Unfortunately, the president’s chosen cost-cutting strategy for Medicare — the establishment of the Independent Payment Advisory Board (IPAB), an all-powerful panel of budget enforcers — is one of the most harmful aspects of ACA. Lawmakers must cast this flawed approach to reform aside and focus instead on innovative initiatives that address the program’s real cost-drivers while protecting seniors’ access to care.
IPAB is a board of 15 presidential appointees. Unelected and unaccountable, these bureaucrats are tasked with drawing up budget cuts if Medicare expenditures exceed preset targets.
Those targets will almost certainly be surpassed. Medicare spending is expected to be $575.7 billion this year, jumping to over $1 trillion by 2022, as the country ages. Over the next 75 years, the program is projected to accumulate a $38 trillion budget shortfall.
Much of this enormous price tag goes towards financing Medicare Parts A and B. And yet, IPAB has no authority over either. In fact, the board can’t make any substantive structural changes. Neither the fee-for-service structure nor enrollee premiums and fees can be altered.
The board’s only viable option is to further ratchet down reimbursement rates for Medicare providers, especially doctors, who are already losing money on Medicare patients. Indeed, the financial burden of too-low payments under Medicare has driven 17 percent of doctors and 31 percent of primary care physicians across the country out of the Medicare program altogether, according to a study from the American Medical Association.
If rates fall any lower, seniors will have an increasingly difficult time securing doctor appointments. Visits will be cut short to squeeze in patients and care compromised.
IPAB is even more insidious because it deflects policymakers’ attention from innovative reform efforts with real cost-saving potential.
Last June, the Department of Health and Human Services (HHS) launched two such initiatives.
The first would make $42 million available to improve coordination of care for Medicare enrollees. Consider that just about half of Medicare beneficiaries suffering from congestive heart failure are readmitted to a hospital within six months of discharge. Each readmission costs an average of $7,000. The health and monetary benefits of improved coordination to make such readmissions unnecessary would be huge. Evidence shows that well designed transitional care between providers can dramatically reduce costs and improve health care outcomes.
Limiting preventable Medicare hospital readmissions could save nearly $245 billion over the current ten-year budget window, according to MedPAC. Even a 40 percent reduction could save $100 billion over that same period.
The second HHS initiative combats chronic illness. This has enormous cost-cutting potential, as 75 percent of health care expenditures go towards the treatment of chronic diseases. Diabetes, heart disease and strokes alone cost $1 trillion annually.
Patient coaching and health education could both improve enrollee health and reduce the costs of treating such illnesses. A clinical trial of the Diabetes Prevention Program found that enrolling overweight adults aged 60-64 in a community-based weight loss program could save Medicare between $1.8 and $2.3 billion over ten years.
Both HHS initiatives hold the promise of saving money and lives. The same cannot be said for IPAB. Instead of generating savings by improving the health of beneficiaries, IPAB devalues these efforts, squeezing doctors and providers to the detriment of seniors.
It’s time to support a Medicare cost-saving strategy that encourages long-term strategic thinking. Congress must repeal IPAB and stand up for real Medicare reform.
Peter Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.
“The health department/City Hall will tomorrow propose that any location that gets a restaurant letter grade will be barred from selling sugar-sweetened beverages over 16 ounces. This would also apply to food trucks.”
And here’s something from the NYC Fox affiliate:
“Get ready to sell smaller containers of soda and other sweetened drinks. The obesity task force with the New York City Department of Health is ready to recommend that containers for sweetened beverages be limited to 16 ounces. The rule would affect drinks sold at delis, fast-food franchises, sports arenas, and sidewalk carts. Anyone who violates the regulation would be fined $200 for every sale.”
I can’t wait for the first 7-11 sting to stop the sale of Big Gulps, the undercover operation to the illegal sale of Mountain Dew refills at movie theaters and the Gatorade bodega/salad bar busts designed to break up multiple bottle sales.
It would also apply to those souvenir soft drink cups at Yankee Stadium, CitiField and Madison Square Garden. But not the 24 ounce beer cups. (As we all know, beer does NOT add weight.)
Or jumbo sno-cones. (I think.) Or coffee with lots of sugar and cream. Then again, will we be allowed to add sugar to our beverages?
I am sure some people actually care if such a regulation will – as Bloomberg claims – reduce obesity. It really doesn’t matter. If obesity rates (using the unreliable measure of Body Mass Index) remain essentially unchanged in The Big Apple(and the have not really budged since 2005 ) since the Mayor started his crack down on sugar and soft drinks ( the consumption of the latter also remains essentially flat) then it will be argued that the assault on serving size is critical.
If Bloomberg claims (incorrectly) – as he has– that the subway ads linking soft drinks to morbid obesity and a ban on soda sales in schools have reduced obesity (and they have not) then a container size crackdown will lead to even greater gains, I mean losses. In fact, sweetened beverage consumption has declined nationwide over the past few years. Do we really know why? No. Does it have any affect on health? No one knows. Are NYC statistics on sweetend-beverage consumption reliable. The data is based on self-reported consumption. For all we know, all the kvetching about soft drinks is just making people lie.. as in telling those conducting surveys what they think they want to know. But who cares? And who in the media has ever looked at the data apart from using it to restate the narrative of evil corporations poisoning our kids. So much for the media being more careful reporting statistics and science after perpetuating the Wakefield vaccine fakery.
We have arrived at this silly place in public policy because the operators of the Nanny State and the media willingly accept the spurious correlation between soda consumption and obesity because it reaffirms pre-existing biases. These biases are reinforced by sloppy “studies” that associate watching TV with drinking soft drinks and both with obesity. Next thing you know NYC is running ads linking soda to leg amputation.
Nagging – by our parents or a billionaire baby sitter with too much time – and one term too many – on his hands has never produced changes in habits, especially eating, drinking and exercise. People – especially in NYC – will find a way to chow and slurp down what they want, when they want.
Which they will. After they stop laughing and ridiculing the latest Bloomberg effort.
The U.S. House of Representatives voted 387-5 on Wednesday to pass its version of PDUFA reauthorization legislation. The bill will now need to be reconciled with a version that passed the Senate last Thursday. Majority Leader Eric Cantor said he hopes to reach an agreement with the Senate by July 4 on a final bill to send to President Obama.
You need to show a decline in rates of death in a randomized clinical trial conducted over ten years in mostly white Europeans
The decline in death rates has to be from all causes, not the disease you were screening for
The determination of what a sufficient decline in death rates is at the sole discretion of USPSTF.
In otherwords, no new screenings such as this new breast cancer detection tool being developed in Israel.
A game-changer in breast cancer detection
Early detection is the key to improving breast cancer survival rates, but mammography is not the ideal method to accomplish this goal. On this point, medical experts across the globe agree.
Not as clear is what could do the job without the disadvantages of mammography — which often causes pain or discomfort; emits radiation; cannot properly image dense breast tissue; relies on a radiologist’s interpretation of the image; and is not recommended for routine screening of women under age 40 or 50.
Of several approaches being developed worldwide, an Israeli solution pioneered by electro-optical engineer Boaz Arnon holds particular promise in providing a game-changing device for early detection of breast cancer.
Arnon’s mother, Ruth, succumbed to the disease in 2004. Through Real Imaging, the company he founded in 2006, he was determined to offer an accurate alternative that would address all issues of concern and still be cost-effective.
Appropriately named RUTH, the device he invented uses a new trademarked platform he calls MIRA (functional Multidimensional Infra-Red Analysis). Built on principles from existing technologies and mathematics, MIRA enables functional quantitative analysis of 3D and infrared signals emitted from cancerous and benign breast tissue.
“Our solution is not sensitive to age or breast density, and works without radiation,” Arnon tells ISRAEL21c. “We image the patient from a distance of 70 centimeters (25.5 inches), with no physical contact or radiation, and we have developed an automatic method that aims to detect breast cancer early, easily and as cheaply as possible.”
No more guesswork
“Physicians should be highly praised for their success rate in diagnosing breast cancer with the tools available today,” says Arnon, “but still, the death rate from breast cancer is unacceptable.”
Breast cancer is by far the most frequent cancer among women, with an estimated 1.38 million new cancer cases diagnosed in 2008 (accounting for 23 percent of all cancers), and is now the most common cancer both in developed and developing regions.
Though a medical doctor will oversee screenings with RUTH, “automatic” is one of its most key features. Results will not have to be interpreted by human eyes, thanks to the device’s unique process of calibration using mathematical algorithms formulated from three-dimensional models of hundreds of women with and without malignancies. The algorithms provide unprecedented accuracy, as Real Imaging has demonstrated in blind studies.
Op-Ed: Comparisons are odious
Agency sets an unhealthy precedent for ‘effectiveness’ research
By Trevor Butterworth Tuesday, May 29, 2012Imagine that all the pharmaceutical companies united to create an institute for quality research, and gave it $1 billion to study “comparative effectiveness” — whether drugs still under patent worked better for people than cheaper generics. Imagine that the pharma companies dug farther into their pockets and came up with another $11 million to train physicians, pharmacists and nurses to be ambassadors for this institute, and that these ambassadors would travel the country offering $4 million worth of further education credits to any doctors or nurses who would agree to listen to their spiel.
If you’re thinking that this is, in fact, what Big Pharma already does, remember, this is still a hypothetical exercise. In reality, such a plan would never get by the Food and Drug Administration, which is to drug marketing what the Spanish Inquisition was to heresy. But if, somehow, such a project were ever to happen, you’d seriously doubt whether it would be unbiased, wouldn’t you? It strains credibility to think that the pharmaceutical industry would go to such expense to say that the cheaper drugs were just as good as the expensive ones.
So guess what the U.S. government has gone and done? It’s given $1 billion to the Agency for Healthcare Research and Quality (AHRQ) to study “comparative effectiveness.” And the agency, in turn, is paying a company — Total Therapeutic Management — $11.6 million to recruit and train doctors, pharmacists and nurses to shill the findings of these comparative-effectiveness studies at high-volume medical practices. As a reward for listening to the government’s spiel, you get a continuing education credit from a $4 million fund.
It’s not clear why the government is using taxpayer money to pay people to sit in a doctor’s office and explain the wonders to be found by going to AHRQ’s website (at present, not many). But in case these busy physicians miss out on this wonderful opportunity for no-cost, taxpayer-funded education, the government is spending another $26 million for a national and regional PR campaign to raise awareness about the program.
But here’s the really amazing thing about the government doing what pharmaceutical companies would be hung, drawn and quartered for doing: Because the government is doing this, it doesn’t need government oversight! Yes, the FDA, which normally polices what can and cannot be said in the promotion of health care, will have no jurisdiction at all over what this sales force will tell health care providers about how medicine should be practiced.
The immediate problem with this is simply the reverse of the problem dogging Big Pharma: If you’ve spent a billion dollars on a new drug, you have an interest in touting it as vastly better than the drug that preceded it. But if you have an interest in saving a billion dollars — and the U.S. government, as the world’s largest payer for health care, most certainly has such an interest — then surely you have a corresponding incentive to recommend cheaper treatments.
All of which leads to the multimillion-dollar, devil-in-the-details question: What does “comparative effectiveness” actually mean?
In theory, it means finding the best treatment for any given medical problem. But how are decisions made about what’s best? What if drug A cures 50 percent of people and costs $1 a pill and drug B cures 52 percent of people with the same problem but costs $10 a pill? The cost savings of, say, treating a million people each year on Medicare by using drug A are huge — but what if you happen to be in the 2 percent for whom only drug B works, and there’s no surefire way to figure that out before treatment?
The problem with comparative effectiveness (according to Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner) is that it’s very different from clinical effectiveness. The former aggregates health care outcomes for a given treatment, while the latter addresses variation within those outcomes — what works best and why, for the individual.
In a recent commentary in Drug Information Journal, Pitts warns that comparative effectiveness, as presently conceived, not only risks derailing the development of personalized medicine, it could end up pushing health care toward the slippery slope of rationing. There is always a trade-off between care and cost, but that trade-off keeps changing as medicine advances. What’s crazy expensive today could be far cheaper in five years’ time, and it could trigger further incremental breakthroughs in treatment.
A glance at the AHRQ’s link-heavy website shows that a lot of its reports are already old, while the billion dollars it got from Congress has yet to deliver any major new findings. This isn’t particularly surprising: Comparative effectiveness research takes time. But what if the eventual results end up being out of date — or get challenged as critically flawed? What will a government “comparative effectiveness” health rep say in such cases?
Again, we don’t know, because the government doesn’t think it needs to regulate itself as a provider of health care research and purchaser of health care. Even if you are an opponent of so-called socialized medicine, you, me and everyone else needs socialized regulation for promoting medicine and treatment. Government should play by the same rules it sets for others. In this case, our future depends on its doing so.
Get ready for many more such outrages: This is the agency that will determine which preventive services ObamaCare will require health plans to cover free of charge.
The task force claims that screening all adult men with the PSA (protein-specific antigen) test doesn’t prevent death from the disease. It argues that “the number of men who avoid dying of prostate cancer because of screening after 10 to 14 years is, at best, very small.”
Adding to the “costs” of the test are “false positives” — they tell people they have cancer when they don’t about 10 percent of the time. The task force thinks this problem makes the cost of screening higher than the tiny benefit screening generates for society.
First, the task force measures the effect of testing on the death rate from anydisease (all-cause mortality). That’s a bogus benchmark, because, as John Maynard Keynes famously noted, in the long run we all die. In fact, death rates from prostate cancer have dropped 57 percent among men ages 49 to 64 and80 percent among adult men over 75. National Cancer Institute data show that prostate cancers are being detected and treated earlier and that life expectancy is rising as a result.
The task force claims there is no evidence that screening directly reduces prostate cancer. But how, then, did death rates decline, if screening doesn’t work?
It does, of course. As prostate-cancer expert William Catalano notes, PSA screening is why the horror of not diagnosing this cancer until it has metastasized (advanced and spread) has all but disappeared.
The task force states that because the PSA test is imprecise, it will always lead to overdiagnosis. But false positives are a risk of all screening, and the error rate for prostate-cancer screening is no higher than screening for other illnesses or cancers.
Catalano also points out that it’s regular testing — not the test being used — that has likely contributed to raising the odds against the disease.
The task force also claims that the PSA test can’t tell us which tumors to treat. Yet it gives the patient and his doctorstime to figure that out.
For most patients, PSA screening gives a 5-to-10-year lead time — a vital window in which other new techniques (needle biopsies plus improvements in surgery and radiotherapy) can work.
Finally, the task force argues that PSA testing causes men to suffer from painful treatments and endure anxiety about false-positive results. It doesn’t measure this cost or have any data to support it. Worse, it disregards the scientific evidence that treatments reduce suffering and improve quality of life, even if they don’t always increase survival.
In reality, this ban is based on politics, not science. The task force — and similar ObamaCare agencies — applies standards that aren’t achievable. Going forward, new technologies would require decades of data and would have to demonstrate they’re nearly 100 perfect before ObamaCare would cover them.
Unless, of course, the procedure is politically popular: ObamaCare will treat contraception as cost-effective, although there’s no hard data to support that claim.
The value of health-care services, in other words, will be measured by political criteria, not by their ability to reduce suffering and death.
That’s an ugly future, indeed.
Counterfeit medicines are growing at such an alarming rate that it finally made it onto the recent Camp David G8 agenda. Counterfeit Avastin has found its way into America’s legitimate supply chain. It’s not just a theoretical problem any more. Now’s the time to close a major loophole that allows the purveyors of false profits to prey on an unsuspecting American public.
Now’s the time for a national standard for pharmaceutical track-and-trace that would enable manufacturers, wholesalers and distributors to provide documentation or a “pedigree” on the chain of custody of drug products, including identification of each prior sale, purchase or trade of a drug, along with the associated dates and parties involved
Earlier this month, 11 people were charged with the March 2010 record-breaking $75 million drug heist from the Eli Lilly warehouse in Enfield, Connecticut back in March of 2010. Fortunately, all of the stolen drugs from the Lilly warehouse were recovered before they could be re-introduced into the legitimate supply chain. But we won’t always be so lucky.
Criminals are going to continue to attack our drug supply because they are always going to be attracted by the high value of drugs in the U.S. market. You can’t prevent criminals from making attempts, but you can make it whole lot more difficult.
Now, while the iron is hot, is the perfect time to strike a blow for drug safety. There’s a general placeholder in the Senate version of PDUFA bill that requires more specifics. Now’s the time for the FDA to roll up its sleeves and work with Congress to come up with a national standard instead of leaving it up to each state to come up with it’s own standard (as in California). In many respects, the only thing worse than no standard is to have 50 different standards that would create 50 different ways for counterfeiters to game the system.
This isn’t a new problem. The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President in 1988. PDMA was enacted to (1) ensure that drug products purchased by consumers are safe and effective, and (2) avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent, or expired drugs. Both Congress and the FDA recognized that such legislation was necessary to increase safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs.
In 2004 (during my service as an FDA Associate Commissioner), I served on the agency’s first Counterfeit Drug Taskforce. Our report outlined a framework for public and private sector actions that could further protect Americans from counterfeit drugs, including implementation of new track and trace technologies to meet and surpass goals of the Prescription Drug Marketing Act (PDMA). Our framework called for a multi-layer approach to address the problem and included the following measures:
- Secure the product and packaging
- Secure the movement of drugs through the supply chain
- Secure business transactions
- Ensure appropriate regulatory oversight and enforcement
- Increase penalties
- Heighten vigilance and awareness
- International cooperation
But the devil is in the details and there’s always the danger of allowing the perfect to get in the way of the (public) good. Implementing PDMA has been a nightmare for 1000 reasons – not the least of which is a single, FDA-mandated track-and-trace technology. But time marches on. Technological advances since 1988 provide a plethora of possibilities. It’s time for the FDA to work with all stakeholders and put a national standard in place.
And the FDA won’t be acting alone. In a May 22nd colloquy, Senators Enzi and Harkin support moving forward with a more permanent and robust solution. Senator Enzi: “The language in the Manager’s Amendment is a placeholder to show our intent to continue working on this critical, but complex, policy.” Senator Harkin: “The logical next step in this policy is to work to improve the safety of the drug distribution system that gets drugs from manufacturers to the pharmacists and other providers who dispense them to patients. The FDA currently lacks the authority to establish a uniform, comprehensive national system to secure the pharmaceutical distribution supply chain.”
The complete colloquy can be found here.
It’s time to give the FDA the authority it needs to put 21st century track and trace into commission on behalf of the public health.
Compulsory what?
Drug regulation in India-the time is ripe for change
The Lancet
To say that India's drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO)-whose remit includes new drug approval, licensing of manufacturing facilities, and regulation of drug trials-is not fit for purpose seems a gross understatement.
A damning 118-page report from the Indian Parliamentary Standing Committee on Health and Family Welfare documents its successive failings. It describes a vast, geographically disseminated organisation that is dangerously understaffed: nine officers at headquarters deal with 20 000 applications, more than 200 meetings, 700 parliamentary questions, and 150 court cases per year. There is also a dearth of medically qualified staff, poor support infrastructure, a seeming lack of coordination between departments, and a scarcity of decent computer systems.
It is therefore not surprising that, of 42 approved drugs randomly chosen for investigation by the Committee, some had not passed through the correct regulatory channels. But the fact that 11 had no phase 3 studies done, 13 "did not have permission for sale in any of the major developed countries", and there was "no scientific evidence to show that...33 drugs are really effective and safe in Indian patients" points to problems at the very foundations of CDSCO. Its mission of meeting the aspirations ... demands and requirements of the pharmaceutical industry", rather than the protection of patients, is a very shaky foundation indeed.
The Committee's report has several suggestions for improvement. However, rather than trying to overhaul an organisation that is failing so catastrophically, India should seize this opportunity to wipe the slate clean and form a new drug regulatory body.
A smoothly running, professional drug regulatory body is essential to ensure, first, that high-quality, adequately assessed drugs are available to India's population and, second, that India's drug industry is regulated well enough to contribute successfully to India's domestic and export sectors. It should go without saying that whatever action India takes, the philosophy of the drug regulatory body should be the protection of patients, wherever they are.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
