Latest Drugwonks' Blog
Just in time for Valentine’s Day comes the Institute of Medicine’s new report, Countering the Problem of Falsified and Substandard Drugs.
Some relevant findings include:
· Congress should fund the FDA to do a national track and trace system, possibly using California as a model.
· The 50 states should adopt NABP's standards for wholesaler licensing (and revocation of license).
· The FDA should publish a list of wholesalers who have lost their licenses from states to, in effect, create a de facto national wholesaler blacklist.
· NIST should setup a repository of counterfeit detection technologies.
Lots of good information.
More good information (and insights) will be at hand at the February 28th conference, The Danger of False Profits: The Threat of Counterfeits to the Public Health. Jointly presented by the Center for Medicine in the Public Interest and the Institute for Policy Innovation, this event will feature speakers iSenior Counselor to the FDA Commissioner John Taylor, Jeff Gren, Director, Office of Health and Consumer Goods, U.S. Department of Commerce, John Clark, Vice President & Chief Security Officer, Pfizer, Michael Maves of Project Hope, Former Executive Vice President and CEO, American Medical Association, Gaurvika Nayyar Research Fellow and Analyst, National Institute of Health, among others.
Event Details:
Thursday, February 28, 2013
9:00 am - 2:00 pm
Reserve Officers Association Headquarters, 5th Floor
One Constitution Ave NE, Washington DC
*Complimentary lunch will be provided
Questions? Please contact Erin Humiston at (972) 874-5139, or erin@ipi.org
President Obama on Medicare,
“We’ll reduce taxpayer subsidies to prescription drug companies and ask more from the wealthiest seniors.”
Does that mean another ill-considered assault on the Kennedy/Daschle Non-Interference Clause and a call for Medicare means-testing? Stay tuned.
“Our government shouldn’t make promises we cannot keep.”
Like "If you like your health care plan, you can keep your health care plan.”
Hm.
“But we must keep the promises we’ve already made.”
Like 12 years of data exclusivity for biologics?
Just asking.
He that promises most will perform least.
-- Gaelic Proverb
I am pleased to announce that Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., a nationally recognized expert in clinical research and development, has been selected as deputy center director for science operations.
With CDER now over 4,000 employees, Dr. Moscicki, in his newly established role, will join Bob Temple, deputy director for clinical science, and Doug Throckmorton, deputy director for regulatory programs, in providing leadership and overall direction to Center activities to ensure that we accomplish our mission most effectively.
Dr. Moscicki currently serves as senior vice president (SVP), Head of Clinical Development at Genzyme Corporation. He joined Genzyme in 1992 as medical director and became the chief medical officer and SVP of biomedical and regulatory affairs in 1996 -- holding that post until 2011.
Over the past two decades, Dr. Moscicki has been responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He is known to be inclusive in his management style and is credited with implementing solid business practices to sustain the company’s long-term operations.
As deputy director for science operations, Dr. Moscicki will share in executive direction of Center operations and provide leadership in overseeing the development, implementation, and direction of our programs.
Dr. Moscicki received his medical degree from Northwestern University Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency with a focus on immunology, followed by a four-year fellowship at Massachusetts General Hospital (MGH) in immunology and immunopathology. He remains on staff at MGH and on the faculty of Harvard Medical School.
His medical, academic, clinical, and regulatory knowledge and expertise – coupled with his strong leadership and organizational management qualifications – make him the ideal candidate for this important position.
Please join me in welcoming Dr. Moscicki. He respects the work that we do and is looking forward to bringing his skills and experience to our Center to assist us in advancing the Agency’s mission.
Janet Woodcock
Less is more.
The CBO report outlining its 2013-2023 projections is not pretty reading -- but there is one exception:
“The largest downward revision in the current baseline is for spending for Medicare’s Part D.” (This citation appears on page 57 of the report.)
The actual data table can be found here.
The ever-accumulating evidence shows that Part D is succeeding beyond all expectations, delivering needed prescription drugs to Medicare beneficiaries for less money than anyone expected—driven by strong competition among plans.
Note to President Obama, if it ain’t broke, don’t fix it.
Smart partnership between government and the free market works.
3D bioprinter and “virus traps” take top startup honors at FutureMed pitch contest
As you’d expect at an event called FutureMed, disruption ruled this week’s event, and Saturday’s startup pitch contest was no exception.
Of the 27 companies that participated, the two that wowed the panel of investor judges the most were seriously outside-of-the-box ideas.
For their “startup to watch” award, the judges chose a company that made a splash in the tech world last fall when Peter Thiel’s foundation put $350,000 behind its novel idea to make more sustainable meat by 3D printing it. That company is ModernMeadow, co-founded and pitched by Andras Forgacs, who’s also one of the co-founders behind the human tissue-focused 3D bioprinting company Organovo.
It was a compelling presentation with some mind-blowing statistics and visuals depicting theresources required to produce a quarter-pound burger. ModernMeadow’s business model also includes a cultured leather product.
The overall startup winner, Vecoy Nanomedicines (Vecoy standing for virus + decoy), is focused on creating a new way to address one of the biggest unmet needs in medicine by outwitting viruses that cause infection.
The Israeli-based company is working on a therapy that uses tailor-made “virus traps” that mimic human cells and cause viruses to attack them. When they attack, the viruses get locked into the decoys and annihilate themselves before they can reach the real human cells, CEO Erez Livneh said. He noted that this new approach to fighting viruses may have the potential to lower the viral load in patients with HIV/AIDS, hepatitis B and C and other infections.
[Disrupt image from BigStock Photos]
“So far, most new (cancer) drugs offer only marginal extensions of life and few cures. “
Now a look at the facts and where Pomalyst fits in the progress we are making against MM. Pomalyst was studied in people with MM who had no other options. As in, their MM was no longer responding to other drugs and they were going to die.
Clinical trials showed that median overall survival for people getting Pomalyst was 13.7 months.
Another study looked at response of patients who were no longer responding to other drugs and whose MM had already come back:
Clinical trials showed halfway into the study that nearly 50 percent of people receiving Pomalyst responded rapidly (as in the MM stopped progressing) and 78 percent had a median surival time of between 3-6 months. Patients receiving Pomalyst were seven times more likely to respond (and live) then those who received an old MM drug.
Now overall survival is the average time half of all patients in a study will live after treatment. So a median survival of 13.7 months means that after 13.7 months, 50% of people with that condition would be alive, and 50% would have passed away. Which also means that many people in the trials are living much longer than 13.7. Or in the other study, 3-6 months.
Several studies have shown that the median survival of people diagnosed with MM has gone from 3 years in 1997 to up to 20 years. The first MM drug was introduced in 1998. Two others were introduced in 2003 (Velcade) and Revlimid (2005) thereafter. W hen age is controlled for, that means an increasing number of people with MM can expect to have the same life expectancy as people who do not have the disease. And we can't measure the full impact of these drugs let alone Pomalyst in a precise manner.
But we can say that MM drugs have increased average life expectancy more rapidly among MM patients than it has average LE in the population as a whole.
And we can say that just as a few HIV drugs introduced over a 5 year period dramatically saved lives, so too have a handful of drugs for MM turned an incurable disease into a controllable condition in less than a decade. And these drugs work because they target specific disease mechanisms in patients for whom they work the best and offer the most hope. The averages are indicators of profound and rapid gains among more and more people.
If we had bought the story about marginal benefits 10 years ago and delayed and dragged out approval and use of other cancer drugs, where would we be today? If we accepted the arrogant assertion that "most new (cancer) drugs offer only marginal extensions of life and few cures.“ how may more people would be dead? Let me go out on a limb and say that while not all new products are useful and effective, the current effort to control health care costs is biased and shaped by this naysaying approach to innovation, an approach delays access to new medicines -- indeed an approach that subsidizes a industry of underachieving social scientists to study average cost effectiveness in an era of personalized medicine -- assures more people will die who did not have to or want to. Recently, the National Pharmaceuetical Council held a conference on The Myth of the Average Patient.. All well and good. But how about a conference on what CER will cost people seeking better medicines for cancer and Alzheimer's in terms of lives saved. My late colleague John Vernon and I did a lot of work in this area but somehow the "stakeholders" always ignore the impact of adding CER to the rate of innovation and the number of lives saved. Why is industry and patient groups silent about the impact of CER on medical progress? What gives?
Finally, why does it take so long to conduct clinical studies. In both of the trials mentioned above, response was immediate and highly effective. (Less than 6 months in most cases). Can't we find other ways to confirm what works and what doesn't? Here's Eric Topol on this important topic..
We have this big thing about evidence-based medicine and, of course, the sanctimonious randomized, placebo-controlled clinical trial. Well, that's great if one can do that, but often we're talking about needing thousands, if not tens of thousands, of patients for these types of clinical trials. And things are changing so fast with respect to medicine and, for example, genomically guided interventions that it's going to become increasingly difficult to justify these very large clinical trials.
We are not just standing in the way of medical progress, we are putting up obstacles based on outdated science and sanctimony.
Herding Katz.
The departure of Rusty Katz as FDA’s Director of the Neurology Products Division is an inflection point in the agency’s 21st century direction. Will his replacement continue his philosophy that the FDA must be a partner in innovation – or will political considerations turn back the clock?
Following Katz at FDA is an important analysis of the situation.
Pleased and proud to report that, according to the Healthcare 100 ranking of the world’s top blogs on health and medicine, Drugwonks is tied for #5. That puts us ahead of the health blog of both the New York Times and the Wall Street Journal.
Thank you for your support – and pass the word!
From the pages of the Des Moines Register (and hello Senator Grassley):
Changes to Part D won't save Medicare
By: Peter Pitts
With a debt-ceiling showdown just around the corner, Republican lawmakers are insisting upon more government spending cuts in exchange for raising the country’s borrowing limit.
President Obama says the debt ceiling shouldn’t be used as a negotiating tool. But it’s inevitable that additional cuts will be seriously considered. And, unfortunately, lawmakers are likely to take aim at Medicare Part D, the highly successful prescription drug benefit.
This approach is misguided. Cuts to Medicare Part D would have devastating consequences for seniors and taxpayers.
Created in 2006, Medicare Part D has helped ensure that America’s seniors have access to prescription drugs. Today, nearly 47 million Americans are eligible for Part D.
The program was built to rely on market mechanisms. Under Part D, seniors choose from a wide variety of drug coverage plans — in fact, there are now over 1,000 different plans available across the country. With so many insurers competing for seniors’ business, they have a strong incentive to keep costs low and benefits generous.
This fierce competition has kept expenses down for both seniors and the government. Overall, Part D has cost $435 billion, or 43 percent less than original estimates predicted — practically unheard of for a government program.
Part D monthly premiums will again average just $30 in 2013, according to officials at the U.S. Department of Health and Human Services. That number has held basically steady for four years, and premiums are up only 2.5 percent since 2006.
Part D rates are even more impressive when compared to what is happening in the regular health insurance market. The typical premium for an employer-sponsored family health plan rose 4 percent from 2011 to 2012 and increased 9 percent the year before, according to the Kaiser Family Foundation.
Seniors, moreover, are pleased with their Part D coverage. A new poll sponsored by Medicare Today found that 90 percent of enrollees are satisfied — up 12 points from 78 percent in 2006.
Still, many Democrats are willing to compromise this highly successful program. Their proposal would require drug companies to pay a so-called “rebate” to the government for every medication sold to a Medicare Part D participant who also qualifies for Medicaid, the government health program for the poor. There are about six million of these dual-eligible seniors.
The Obama administration believes that its plan to overhaul Medicare spending will save nearly $600 billion, with 42 percent of those savings coming from the Part D drug rebates.
But this scheme won’t work the way the president intends. It will drive up health care costs for a large portion of Medicare beneficiaries.
Just look at what is already happening in our Medicaid program. Drug companies are required by law to sell their wares to Medicaid at below-market prices, and consequently they have been forced to raise prices elsewhere. In other words, the proposed Part D rebate program would effectively levy a new tax on every senior who is not eligible for Medicaid.
Indeed, two independent studies have estimated that the rebate plan will raise premiums for traditional Medicare enrollees by 20 to 50 percent.
Higher premiums are a big concern for most Part D beneficiaries. According to the Medicare Today poll, 84 percent of enrollees were worried that a Part D restructuring would increase their out-of-pocket drug costs, while 53 percent were afraid it would cause them to cut back or stop taking their medicines altogether.
Our government health programs are still in serious need of comprehensive reform. Unfortunately, the president continues to attack the very part of the system that is most financially sound. Changes to Medicare Part D will raise only minimal revenue — at the expense of seniors.
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.
