Latest Drugwonks' Blog
“The convergence of two powerful forces is driving today’s medical innovation to the top of the national agenda: The urgent need for medical breakthroughs and the unprecedented opportunities created by recent advances in science.”
So said El Lilly & Company’s Grand Poobah John Lechleiter at yesterday’s “Advancing Medical Innovation” summit in Washington, DC. (The event was co-sponsored by Lilly and the Washington Post.) I was pleased to attend.
More Lechleiter:
“Our only hope of breaking our of the crisis is through innovation that changes the terms of the trade-offs we must make and expands the scope of what’s possible.”
The Hoosier Honcho then offered a very potent example of what he meant:
“In the early 1950s, the cost of polio care in the US was predicted to be $100 billion by the year 2000 but, thanks to the advent in 1954 of the polio vaccine, the cost of treating polio in the US in the year 2000 was $100 million.”
In other words – the prediction was off by 99.9% because of game changing innovation. Can we do that again? We’d better try – and try hard.
But Lechleiter offered a crucial caveat, “Realizing the benefits of medical innovation requires an ecosystem where innovation can thrive.”
Are we there yet?
President Obama is wooing seniors with promises to protect Medicare as they've known it. On the defensive because of the $716 billion his health care law takes from Medicare, Obama assures seniors he's cutting payments to hospitals and other providers, not their benefits.
Don't be bamboozled. It's illogical to think that reducing what a hospital is paid to treat seniors won't harm their care. A mountain of scientific evidence proves the cuts will worsen the chance that an elderly patient survives a hospital stay and goes home. It’s reasonable to conclude that tens of thousands of seniors will die needlessly each year.
Under ObamaaCare, hospitals, hospice care, dialysis centers, and nursing homes will be paid less to care for the same number of seniors than if the health law had not been enacted. Payments to doctors will also be cut.
Read more here.
Politico on the Hatch Act violation by HHS Secretary Sebelius:
INDEPENDENT COUNSEL: SEBELIUS CROSSED THE LINE - Limits on political maneuvering by public officials working on the taxpayers' dime are nebulous, byzantine and often blurred. But the Office of Special Counsel - an independent prosecuting authority - has concluded that HHS Secretary Kathleen Sebelius broke the law when she exhorted a North Carolina crowd last February to reelect her boss, President Barack Obama, during what was supposed to be an official visit. The determination - which OSC said was an isolated incident - creates an immediate headache for the Obama administration on a day that Census data showed a dip in uninsured Americans, partly because of the Affordable Care Act.
--From the OSC report: "[Sebelius] noted that North Carolina is critical in the next election and emphasized that it is 'hugely important to make sure we reelect the president.' These statements were made in Secretary Sebelius's official capacity and therefore violated the Hatch Act's prohibition against using official authority or influence to affect the results of an election."
--Sebelius admitted she shouldn't have injected politics into an official event but pointed to her office's immediate decision to reclassify the event as a campaign stop and to reimburse the U.S. Treasury for her travel. More telling, though, was her explanation for the lapse: "As I have also explained, keeping the roles straight can be a difficult task, particularly on mixed trips that involve both campaign and official stops on the same day."
Read more here.
Much important discussion of late about possible new categories for Rx-to-OTC switching – namely erectile dysfunction medicines and statins. But how does this impact consumer information? Consider the impact of the FDA-to-FTC switch.
The FDA requires prescription drug advertising to provide consumers with a "fair balance" of risks and benefits. The FTC, on the other hand, holds drug advertisements to the same standards as other consumer products, requiring a "reasonable" standard of truthfulness.
What’s the impact on how these products are presented to consumers?
According to a new study, when prescription drugs become available over-the-counter, advertisements for the medications are less likely to tell consumers about the potential harms and side effects. This according to Dr. Jeremy Greene, an associate professor in the history of medicine department and the department of medicine at Johns Hopkins University (study published in the September 12th issue of the Journal of the American Medical Association).
Greene and his colleagues analyzed print and broadcast advertisements for four commonly used drugs that were heavily marketed to consumers as prescription drugs and then approved for sale over-the-counter.
The drugs included loratadine (brand name: Claritin, sold over-the-counter since 2002), omeprazole (brand name: Prilosec, went over-the-counter in 2004), orlistat (brand name: Alli, Xenical, sold over-the-counter since 2007), and cetirizine (brand name: Zyrtec, sold over-the-counter since 2008).
When the drugs were available only by prescription, 70 percent of the ads mentioned potential harms. After the drugs were available over-the-counter, only 11 percent did, the investigators found.
After drugs became available over-the-counter, only about half of print and broadcast advertisements mentioned a drug's generic name, compared to 94 percent of ads when drugs were prescription-only. Knowing a drug's generic name can help consumers make sure they're not taking more than one medication that has it as a component, risking overdose, Greene explained.
Greene believes that the FDA should be given authority to regulate marketing of over-the-counter drugs, or perhaps the FTC should adopt guidelines similar to what the FDA requires.
Rather than asking either underfunded agency to take on more work (for which they are neither staffed nor suited), perhaps OTC advertisers should consider what they could do to better educate consumers. After all, a key FDA consideration in approving an Rx-to-OTC switch is whether consumers understand key communication objectives of the label, relating to directions for use, contraindications, in-use warnings and precautions.
Knowledge is power.
A very interesting post from pointoflaw.com:
FDA's "graphic" cigarette warnings struck down
The FDA has suffered another setback in its relentless campaign to turn every cigarette pack into a "mini-billboard" for its anti-smoking agenda. The US Court of Appeals for the DC Circuit has upheld a lower court decision striking down the agency's rules that would require cigarette makers to include certain government-approved "graphic warnings" against smoking. Nothing too extreme, mind you, just a man blowing smoke out of a tracheotomy hole and similar pictures.
As reported last November, U.S. District Judge Richard Leon initially granted a preliminary injunction against the FDA rules. In February of this year, he issued a final ruling striking down the graphic warning requirement as unconstitutional "compelled speech." The DC Circuit affirmed on August 24.
The Supreme Court has long recognized that the First Amendment right to say what you want would be meaningless if the government could force you to say things you don't want. In Wooley v. Maynard, for example, the Court affirmed that Jehovah's Witnesses in New Hampshire could not be forced to use license plates with the State's motto: Live Free or Die.
Although commercial speech often merits less protection under existing precedents, there is clearly a liberty problem with forcing manufacturers to do everything possible to dissuade potential customers from buying their product. As the DC Circuit points out, manufacturers have been compelled to include certain information on labeling or other advertising if the information is (1) strictly factual, and (2) without the information, the company's advertising would be misleading. In this case, however, the FDA doesn't argue that current cigarette labels are misleading -- they include all the textual warnings. The FDA just thinks that the packages aren't scary enough; thus, they would require that 50 percent of the front and back panels of every cigarette pack contain pictures, e.g., of women crying, small children, and the guy with the tracheotomy. As the DC Circuit concluded, the images do not convey factual information, but are "unabashed attempts to evoke emotion (and perhaps embarrassment) and browbeat customers into quitting.
And yet, the government would have the courts review its rules under the weakest form of scrutiny available. By the FDA's logic, the government could dictate that every stick of butter be wrapped in images of open-heart surgery, that every candy bar be emblazoned with pictures of rotting teeth, and every sugary drink carry images of obese children -- and these rules would be virtually unreviewable.
The FDA could not even produce evidence that the graphic images would be effective -- the agency estimated a mere 0.088 decrease in smoking rates as a result of the shock-and-awe campaign. Ultimately, the agency seems to want the graphic warnings because "everybody else is doing it." The FDA cited a "strong worldwide consensus" based on the actions of various countries, including Mongolia, Venezuela, Singapore, and Iran. " It is worth noting," the Court said, "that the constitutions of these countries do not necessarily protect individual liberties as stringently as does the United States Constitution." You can say that again.
The case is R.J. Reynolds Tobacco Co. v. FDA, No. 11-5332, slip op. (DC Cir. Aug. 24, 2012).
From the pages of Medical Marketing & Media …
Amid misspent billions, the promise of personalized medicine
The Institute of Medicine has released a report putting the cost of unnecessary medical care at $750 billion a year and counting. What does it mean for pharmas? Depends on how you read it.
The IOM determined that three quarters of a trillion dollars (yes, that's trillion, with a ‘t') in health spending was wasted in 2009 – around 30% of all US healthcare spending – due to unnecessary services rendered, excessive administrative costs, fraud and other causes. Unnecessary services accounts for the largest chunk of that number, at around $210 billion, followed by “excess administrative costs,” at $190 billion, and then “inefficiently delivered care,” including mistakes and the unnecessary use of pricey providers, at $130 billion. “Prices that are too high,” defined as “services and products beyond competitive benchmarks,” costs $105 billion, while fraud runs $75 billion and “Missed prevention opportunities” $55 million.
Expressed through a different, and starker, metric, IOM noted estimates that around 75,000 deaths might have been averted in 2005 had all states delivered care as well as the best-performing ones.
While the report, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America,” doesn't have much to say about costs associated with drugs and biologics, specifically, it could provide fodder for advocates of European-style cost curbing for federal programs, but it also adds urgency to the movement towards personalized medicine.
“The slippery slope to comparative effectiveness is there,” says Peter Pitts of the Center for Medicine in the Public Interest. He worries that a price control scheme like the UK's NICE could be implemented in the name of efficiency, but also sees the report's findings dovetailing nicely with the drug industry's move towards more narrowly targeted drugs, biologics and diagnostics.
“If the idea is to get the right treatment to the right patient at the right dose as early in the cycle as possible, even if that sometimes means a more expensive drug rather than a generic, that's going to save money over the “fail your way to success” route [of cycling through multiple treatments until one works],” said Pitts.
The IOM sees several big factors impeding efficiency in US care delivery – chief among them, the lack of price transparency and collaboration between across providers, institutions and other players. And then there's the sheer complexity of modern healthcare, made all the more daunting by Big Data and the rapidly multiplying number of available therapies and procedures.
“The US healthcare system is characterized by more to do, more to know and more to manage than at any time in history,” says the report.
As medical technology has progressed, the volume of information available to practitioners has multiplied exponentially. The number of journals and other research publications has more than tripled over the past four decades, from 200,000 in 1970 to 750,000 in 2010, the report notes.
The IOM is an influential body of the National Academy of Sciences whose pronouncements can have far-reaching effects on regulators and policymakers. In recent years, the group has taken on thorny topics like consumer advertising of prescription drugs, CME and industry influence on the practice of medicine.There are many patient advocacy organizations. Most are more interested in getting a "seat at the table" of the Washington policy community. A few, like Everylife Foundation for Rare Diseases, are focused on removing the barriers to faster and broader access. The group was the leading voice for reforms that accelerate the development of drugs for rare disease.. You can join it's movement for medical progress by voting for a Rare Voice Award honoree. Here's a link to the nomination page: http://rarevoiceawards.org/nominate/
The number of deserving awardess are growing. Just nominating someone can shine a light on their efforts.
OPQ, I see you
BioCentury reports that the FDA is considering the creation of a new office to oversee quality throughout the lifecycle of a drug.
According to CDER Director, Dr. Janet Woodcock, the new Office of Pharmaceutical Quality would take on some of the functions currently within the Office of Pharmaceutical Science, as well as some functions from the Office of Manufacturing and Product Quality in the Office of Compliance. Woodcock said it is imperative that CDER "have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety."
Woodcock also proposed to elevate the Office of Generic Drugs to a "super" office as a result of the new user fee program for generics. OGD Director Greg Geba would continue to lead the office and would report to Woodcock.
And speaking of adaptive clinical trials
Exciting story in the New York Times about advances in treatment for squamous cell lung cancer and, “a new type of treatment in which drugs are tailored to match the genetic abnormality in each patient.”
The study is part of the Cancer Genome Atlas, a large project by the National Institutes of Health to examine genetic abnormalities in cancer. The study of squamous cell lung cancer is the second genetic analysis of a common cancer, coming on the heels of a study of colon cancer.
“As a result, the usual way of testing drugs by giving them to everyone with a particular type of cancer no longer makes sense. So researchers are planning a new type of testing program for squamous cell cancer that will match the major genetic abnormality in each patient with a drug designed to attack it, a harbinger of what many say will be the future of cancer research.”
“The old way of doing clinical trials where patients are only tied together by the organ where their cancer originated, those days are passing,” said Dr. Mace Rothenberg, senior vice president of Pfizer oncology.
A judge in the U.S. District Court for the District of Columbia has dismissed KV Pharmaceuticals suit against the FDA over the company's preterm birth drug Makena hydroxyprogesterone caproate.
After developing an FDA approved version of a drug that was in danger of becoming obsolete, KV promptly – and without warning – decided to charge $1500 per dose. The company was rightly criticized for the sudden jump in price and did the right thing by cutting the retail price of the drug to $680 and offering the drug at a reduced price to a wide range of organizations.
And yet the FDA decided to allow pharmacists to continue compounding even though KV developed the drug to put an end to the risk associated with compounding products. (FYI -- The FDA is currently Investigating bacteria that sickened 19 people at Alabama hospitals and may have killed nine and has turned up at compounding pharmacy in Alabama. And there are many other examples.)
Is this a victory for the public health?
KV filed suit against the FDA, alleging that the agency's policy of non-enforcement for compounded hydroxyprogesterone caproate products violated KV's right to market exclusivity for Makena under the Orphan Drug Act.
No dice.
Judge Army Berman said KV's allegations relate to FDA's discretionary enforcement activities and are therefore "unreviewable claims." She said in her ruling that the "case is fundamentally an effort to get the court to direct and oversee the FDA's enforcement activities, and that it cannot do." We agree with Judge Berman -- but it's a dangerous precedent.
Last month, KV filed for Chapter 11 bankruptcy because it has been "unable to realize the full value" of Makena, citing FDA's lack of enforcement of the market exclusivity.
Is this a victory for pregnant women?
Certainly the FDA has the authority to ensure the availability of products and indirectly considers affordability. It did so when it kept generic asthma inhalers on the market for several years rather than forcing them off to comply with an EPA requirement to remove inhalers powered by CFCs. I was at the agency at the time and the issue of inner city access was hotly debated.
That was (IMHO) a considered and organized action based on much thought and many meetings with stakeholders. The KV action (IMHO) was a reaction to media hype and political pressure. The FDA even got involved in a little demagoguery when it cited the fact that the NIH had provided KV with support to conduct clinical trials as the agency’s reason to allow the compounding. Given that logic, should every drug developed in cooperation with the NIH or based on NIH research be denied market exclusivity?
If the White House mandates the sequestration of the FDA budget the hurt will be shouldered by the public health.
PDUFA dollars cover reviews – but what about all of the other non-user fee items the FDA has on its plate – like advancing regulatory science and combatting counterfeiting, and developing standards for biosimilars and enhancing the safety and security of our food supply – to name only a few?
Sequestration = Castration of the FDA's mission.
Less is not more.
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.
