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Last night Peter and I were surrounded by people who celebrated Dr. Sol Barer, CEO of Celgene for his leadership and vision in transformational medicine. They and we were graced by the warmth and wit of John Stossel, Rich Bagger, Mike Ferguson, myleoma survivor Elijah Alexander, and Dr. Jules Hirsch -- individuals who are leaders in their respective fields of journalism, the pharmaceutical industry, politics, professional football and academic research. Their charge to us, at the First Annual CMPI Odyssey Dinner, was to dare and endure as they have, on behalf of medical innovation. We were called upon to speak out, to make biomedical innovation a personal and passionate cause -- and to battle against those who vilify its capitalist origins.
I can't thank enough those who gathered with us to begin this new movement -- friends old and new -- for their support, generosity, warmth and participation. Above all, I am left with a memory of your kindness, the appreciation of which I look forward to repaying in the months and years ahead!
Thank you.
"The Budget supports the Food and Drug Administration’s (FDA’s) new efforts to allow Americans to buy safe and effective drugs from other countries ..."
Don't kid yourself by thinking this has anything to do with lowering costs for seniors (because even the AARP says Part D is a better deal) or "broadening access" for the uninsured (which is what pharmaceutical patient assistance programs are for). Importation is yet another stealth strategy towards a straight up price control regime for medicines. If importation goes forward, you don't need to revoke the Non-Interferene Clause. This has been Rahm Emanuel's strategy for the past few years and now he's an agent in place.
If you like "universal care" provided by Uncle Sam, MD -- you're going to love importation.
Here we go again.
Sing in me, Muse, and through me tell the story
of that man skilled in all ways of contending,
the wanderer, harried for years on end,
after he plundered the stronghold
on the proud height of
So begins Homer's Odyssey. And so began last night's first annual Center for Medicine in the Public Interest Odyssey Award gala dinner.
The dinner (held at the posh Short Hills Hilton) honored Sol Barer, PhD, CEO and Chairman of Celgene, for his lifetime of dedication to the cause of medical innovation. (Watch this space soon for his complete remarks.) Sol is a visionary and the evening was all about him -- but he is all about innovation in the service of patient care.
And while Dr. Barer got the trophy, the hero of the evening was Elijah Alexander, ex-NFL linebacker, husband, father of two -- and survivor of multiple myeloma. (For more on Alexander's fight against multiple myeloma, visit the "Tackle Multiple Myeloma Foundation" website here.)
Elijah talked about his cancer, about the impact it had on his family -- and how innovation saved his life (specifically via Revlimid). He cried. Everyone cried. Even John Stossel, Mr. "Give Me A Break" (and the evening's emcee), misted over.
The evening was all about the importance and urgency of innovation.
Yes -- even innovation via the resurrection of thalidomide.
President Obama says he want to "cure cancer." He should talk with Sol Barer.
But first he should listen to Elijah Alexander.
1. I don't like tax increases. However capping the deductibility of health care expenses at some point does make sense. So does taxing benefits beyond a certain dollar value or income level (inflation adjusted). Obama got that half right.
2. Requiring HMOs to bid using the Medicare actuary's estimate was something President Bush proposed in 2003. Most people don't remember that. Now Obama is proposing the same thing in lieu of the bonus. Will seniors pay more or less? Will they be better off? Hard to predict.
3. No price controls on part D which rewards use of market forces and preventive technologies. Cuts to medical imaging and home health which will likely not stand or will be adjusted.
4. The administration proposes a bundled hospital payment that includes 30 days for post discharge care. Can we say DRG-based capitation? Nothing new here...just another reimbursement code to exploit.
The Obama team did as little as prescriptively possible to come up with $700 billion for universal health care. More -- about a trillion more (at least) will be needed and even then not everyone will be enrolled. And of course enrollment does not equal better health or outcomes. Where will the rest of the money come from? A tax on employers in lieu of providing coverage.
So for the most part the health care reforms are nothing new and the cost is very high. Still, the down payment does little to move us towards "government run" health care. If free market types want to come up with a way to provide people with a choice of health plans that eliminates penalties for pre-existing conditions and a range of insurance products that are affordable that does not involve government control over medical decisions, now is the time. It can't be HSAs alone, which are still a confusing and difficult benefit to provide. It has to protect people from financial catastrophe, reward healthy behavior, reward better outcomes, encourage more personal responsibility. And the proposal has to be bold and big.
Nothing else will compete or do.
According to a story in today’s Washington Post, “President Obama is proposing to begin a vast expansion of the
(And this isn't counting the unemployment insurance-eligible Americans and their families who now qualify for government benefits as part of their unemployment benefits.)
Not surprisingly (in advance of the budget) light on details. No surprises.
Per healthcare reform, two words that may serve as tea leaves -- "down payment" and "affordable."
"Down Payment" = incremental.
"Affordable" = insurance reform.
Relative to "affordable," here's are a few paragraphs from the recent Robert Pear story in the New York Times:
Since last fall, many of the leading figures in the nation’s long-running health care debate have been meeting secretly in a Senate hearing room. Now, with the blessing of the Senate’s leading proponent of universal health insurance, Edward M. Kennedy, they appear to be inching toward a consensus that could reshape the debate.
Many of the parties, from big insurance companies to lobbyists for consumers, doctors, hospitals and pharmaceutical companies, are embracing the idea that comprehensive health care legislation should include a requirement that every American carry insurance.
While not all industry groups are in complete agreement, there is enough of a consensus, according to people who have attended the meetings, that they have begun to tackle the next steps: how to enforce the requirement for everyone to have health insurance; how to make insurance affordable to the uninsured; and whether to require employers to help buy coverage for their employees.
The ideas discussed include a proposal to penalize people who fail to comply with the “individual obligation” to have insurance.
“There seems to be a sense of the room that some form of tax penalty is an effective means to enforce such an obligation, though only on those for whom affordable coverage is available,” said the memorandum, prepared by David C. Bowen, a neurobiologist who is director of the health staff at the Senate Committee on Health, Education, Labor and Pensions.
The full New York Times story can be found here.
Another question worth pondering is wither Medicare Advantage?
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Court verdict could give generic drug makers an unfair advantage
Generic drug companies are pressuring Congress to pass a bill that would profoundly alter how drugs are developed and sold. Supporters claim the measure will expand choice and lower prices for consumers. The truth, however, is that it will limit competition and drive up prices.In recent years, the generic drug industry has been growing by leaps and bounds. Once seen as fringe players, generics now account for 65 percent of all U.S. prescriptions and post $59 billion in annual sales.
In fact, the generic market has been growing faster than the brand name drug market. This explosive growth has brought with it increased stature and influence. And the generic drug industry is not shy about flexing its newfound muscle in legal and legislative arenas.
Drug innovators can spend 15 years and more than $1 billion discovering, developing, testing, and bringing a successful drug to market. In return for this tremendous investment, pharmaceutical companies are given a patent, generally for 20 years, during which they alone can sell the drug.
This exclusivity period often includes the years spent in research and development, so drug companies don’t have very long to recoup their investment. And once a patent expires, generic drug makers are able to offer their version of popular drugs.
Not saddled with massive R&D expenses, generic companies can offer the drug at a fraction of the cost of the original, allowing them to quickly gobble up the market share.
Currently, the first generic manufacturer to win government approval can market their version of the drug without competition for six months. Often, the original drug innovator creates its own generic, called an “authorized generic,” and wins this brief exclusive marketing period.
The bill currently before Congress will outlaw authorized generics, paving the way for generic-only companies to move their version to market more quickly.
Proponents say this will lower prices for the generics, but the evidence suggests otherwise.
Historical data demonstrate that authorized generics are usually introduced to the market at a 50 percent discount. Straight generics, on the other hand, are introduced at a 30 percent discount.
In addition, once the six-month exclusivity period is up, the market is open to all generics, and the more there are, the lower the prices for consumers. Arbitrarily banning one of those generics is not only unfair to consumers, it also creates a disincentive for drug innovators to invent new cures.
The development of new drugs is a risky and expensive process, so anything the government does to obstruct companies from recouping their investment tends to have a chilling effect on drug innovation.
Which is why a recent decision by the California Supreme Court in the case of Conte v. Wyeth is so troubling.
The plaintiff, Ms. Conte, became quite ill after taking a generic heartburn medication prescribed by her physician. Conte not only sued the generic manufacturer, but also Wyeth, the company that made the original brand name drug, even though she never ingested any medicine made by Wyeth.
Because her physician admitted he had not read the warning labels for the generic drug he prescribed, but rather relied on the Wyeth warnings he had been exposed to decades earlier, Wyeth was found liable for Conte’s injuries.
Pushing the bounds of common sense even further, the generic manufacturer has been excused from the case entirely. Why? Because even though they made the actual product that harmed Conte, the physician hadn’t read their warning label.
This case sets a potentially disastrous precedent. In addition to doing all the research, development, testing, trials, and advertising for new drugs, innovators must also assume the legal liability for their competitors when they someday market a generic version of the drug.
In our already-litigious society, it is difficult to imagine a greater deterrent to developing new medications.
Generic drugs are widely trusted by Americans, as they should be. But however safe their products are, the policies the generic industry is pushing are anything but. They threaten to eliminate competition, drive up prices, and stifle innovation -- all prescriptions for catastrophe.
Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
http://www.ama-assn.org/amednews/2009/02/23/prsa0223.htm
"Sunshine" bill sets $100 trigger for disclosing drug industry pay to doctors
The proposal would let states regulate such income even further. Reflecting a growing trend, two universities and a specialist group announce new conflict-of-interest policies.
"Physicians who receive $100 or more from drugmakers or device manufacturers over the course of a year would have those payments posted to the Web under bipartisan Senate legislation introduced in January.The new bill is stricter than a version of the measure circulated last year that received support from industry and organized medicine groups, including the Pharmaceutical Research and Manufacturers of America and the American Medical Association.
The reintroduced legislation, known as the Physician Payments Sunshine Act, came amid another round of disclosure and conflict-of-interest policies announced by doctors and academic health systems."Note that none of these disclosure or conflict of interest policies or limits on marketing announced by academic health systems restrict the ability of academic health systems to uh..market to the public, pay doctors out of central funds, receive and transfer money from insurance companies, hospitals, the for-profit arms of the health systems themselves, the lobbying or law firms that might retain the physicians from the academic health systems for expert legal work. Oh no. That exemption is about a wide as the part on Senator Grassley's scalp.
And since we have no regard for the civil liberties of physicians and their family members...."The bill also would require drug companies or device makers that are not publicly traded to disclose any ownership interest held by physicians or their immediate family members. " Does that mean if Dr. Berkowitz invests his son's Bar Mitzvah money in a hedge fund that also holds a position in a start up seeking to cure cancer that it is the responsibility of the start up to track down that investment?
Some university health systems have gone to idiotic lengths to prove to Grassley how pure they are..."University of Iowa Health Care, a 1,420-physician health system, also announced a stricter financial-conflict plan in January. Among other things, the new policy bars faculty, staff and trainees from seeking, accepting or giving patients product samples under the theory that the free drugs improperly influence prescribing habits." Nice theory. But is it true? And what if samples allow doctors to monitor if patients actually respond well to drugs without burdening patients with out of pocket costs? Doesn't that improperly influence prescribing habits? Since co-pays seem to drive down compliance in many cases isn't this policy harmful to patient health in order to appease Grassley? And meanwhile it hasn't stopped UI from boosting the amount of dough it spends marketing itself to the various insurance providers in the area.
In any event, I agree with Senator Grassley tha "Shedding light on industry payments to physicians would be good for the system. Transparency fosters accountability, and the public has a right to know about financial relationships." So with that, the Sunshine Act should be amended to include any payment to physicians and any financial relationships in the health care industry. That includes when foundations and law firms pay physicians to travel to cushy locations to pontificate about drug and devicemaker influence in Bermuda and when the same pay doctors to conduct studies, publish reports and hold conferences. That includes when doctors are paid as expert witnesses and or receive any sort of gift, food, compensation of any value over $100 to advise, consult on policy or legal matter. That includes when academic health centers and hospitals pay for CME curriculum, as well as travel, food and lodging. That includes any time a physician is paid to conduct research, participate on a panel or advice a government agency, insurance company, benefit manager, HMO, etc that can influence a cilnical decision, guideline development, etc. And why stop at $100. Why not $50 or $25? Why stop at doctors? Why not nurse practitioners, pharmacists, home health workers, infusion specialist, lab technicians?
Here's the beginning to whet your appetite:
If it were not for the great variability among individuals, medicine might as well be a science and not an art.
— Sir William Osler (1892)
Over the past half century, biomedical science has developed randomized, controlled clinical-trial methods that can distinguish treatment effects from the noise of human variability. Positive results from tests of a treatment in a randomized, controlled trial provide great confidence that an intervention improves a prespecified outcome in a population defined by explicit entry criteria. These methods are rightly venerated because they have helped move medicine from anecdote to science and have largely brought about the therapeutic advances of the past 50 years. However, although population-based, randomized, controlled trials of drugs control for disease variability, they generally do not reveal why some people do not have a response to treatment, others have excessive pharmacologic responses, and still others have side effects that occur in a distinctive pattern for a given drug. Addressing this question is our next challenge.
Currently, medicine is addressing this challenge through the lens of genomic technologies. There is considerable debate about the quality, quantity, and type of evidence that would be needed to change clinical practice by introducing pharmacogenetic testing for a given drug. What methods should be used to understand individual responses once an overall population benefit has been shown in randomized, controlled trials?
The full editorial can be found here. It's a timely and important read.
"As a result of this increase in the quantity of relevant information, synthesized information such as systematic reviews, clinical guidelines, and resources (e.g., The Cochrane Library), have become essential tools for the users of the evidence (Druss and Marcus, 2005). However, the number of these products has also grown substantially. For example, as of September 2007, the Agency for Healthcare Research and Quality’s (AHRQ’s) National Guideline Clearinghouse (2007b) listed 54 clinical practice guidelines under the heading “antihypertensives.” In this situation, end users need a mechanism to determine which summaries are the most relevant, valid, and reliable." This is according to an Institute of Medicine study:
Knowing What Works in Health Care: A Roadmap for the Nation (2008) Board on Health Care Services (HCS)
So the key to improving the practice of medicine is to rely on the summaries which are -- according to the HMO-run and beholden institutes that do most of the work for AHRQ and their HMO heavy stakeholder group -- the most relevant, valid and reliable....Or is it about cost?
Jean Slutsky, who will essentially be in charge of the billion or so that AHRQ spends compares her agency favorably to NICE in the UIK among others:
"Health care expenditures are growing faster than incomes for most developed countries, jeopardizing the stability of health care systems globally.1 This trend has led to interest in knowledge about the most effective use of health care worldwide. To increase the value of health care services, many countries have established programs or independent agencies that inform health care decisionmaking through systematic reviews of technologies, pharmaceuticals, and other health care interventions. A few examples include the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, the Haute Autorité de Santé (HAS) in France, and the Canadian Agency for Drugs and Technologies in Health (CADTH)"
As I have mentioned here and here AHRQ has a cozy relationship with NICE analogues established by HMOs:
"We have something that looks somewhat analogous in many of the domains in which NICE is working," says Joseph Newhouse, Ph.D., professor of health care policy at Harvard Medical School and a former member and vice-chair of the Medicare Payment Advisory Commission (MedPAC). It's just not "pulled together in one agency with a crisp mandate."
Starting with the private sector, there are a number of technology assessment groups that analyze drugs, devices, and procedures—the most well known of which is the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). "It has been around for about 10 years and is definitely considered the most rigorous of the groups," says Barbara J. McNeil, M.D., Ph.D., a professor and head of the Department of Health Care Policy at Harvard Medical School who is a member of TEC Medical Advisory Panel.
TEC completes 20 to 25 assessments of drugs, devices, and procedures each year, usually for treatments with increasing requests for coverage but unclear value. A recent example is the use of electron beam CT (computed tomography) for the evaluation of patients with suspected cardiac disease. The TEC staff completes a detailed review and the Medical Advisory Panel uses this information to make a judgment about its clinical effectiveness.
Kaiser Permanente and the Centers for Medicare and Medicaid Services (CMS) are among TEC's clients. Similar groups include ECRI (formerly the Emergency Care Research Institute) and Hayes Inc. Many health plans, including CIGNA HealthCare, have their own internal medical technology assessment groups.
Read more here
It should be noted that ECRI and Hayes Inc. helped write the IOM report on comparative effectiveness and ECRI has also done work on the use of CT scans for heart disease... And I will save my analysis of how TEC and ECRI systematically ignored the predictive value of CT scans in detecting early onset of heart disease better than other treatments for another time. Suffice to say that ARHQ is hell-bent on the summarizing of the "available" evidence as selected by a select few of individuals whose computers seem to have tunnel vision when it comes to searching for the truth.
I have heard the rhetoric of the AHRQ folks in various settings. Some of it sounds good. And some of the studies they have sponsored with respect to alternative evaluation methodologies are valuable but too few to make a difference.
CMPI has even offered to help fund and sponsor conferences to promote patient-centered approaches to comparative effectiveness research. No response from either Clancy or Slutsky. I guess they are content to publish reports that continually claim that there is insufficient evidence for....etc. That disclaiimer is just enough to let health plans say no to any number of existing or new treatments.
It will kill innovation and hurt millions without saving money...
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.
