Latest Drugwonks' Blog
America’s biopharmaceutical research companies invested a record $67.4 billion last year in the research and development of new medicines and vaccines – an increase of $1.5 billion from 2009, according to analyses by the PhRMA and Burrill & Company.
PhRMA member companies alone spent an estimated $49.4 billion on biopharmaceutical R&D last year, a 6.5 percent increase over 2009, according to the PhRMA survey. The Burrill & Company analysis shows that additional biopharmaceutical research companies in the United States spent an estimated $18.0 billion on R&D in 2009.
More than 75 percent of research dollars were invested in the U.S.
Over the past decade, biopharmaceutical companies have consistently invested around 19 percent of domestic sales on R&D activities; in 2010, that figure jumped to 20.5 percent.
While many often disagree with Jeff Shuren, those of us who know him and have served with him know him as an honorable man and a dedicated public servant.
Using words like “perjury” to advance an agenda (even, in this case, one that I mostly support) is inappropriate. Intelligent people can (indeed must!) regularly disagree on many things. That's how progress is made.
As background, some reportage courtesy of the talented Matt Herper at Forbes.
FDA Says Official Did Not Lie Under Oath
Jeffrey Shuren, now the head of the FDA’s Center for Devices and Radiological Health, was asked at a Congressional hearing last July if direct-to-consumer genetics companies like 23andMe and DeCodeMe add to the medical literature by doing their own research. He said no.
“From the information we know,” Shuren said, “they are not doing their own research on the genetic profiles but they’re interpreting the studies that have been performed by others.”
FDA critics pointed out that Shuren had just days before those comments listened to a presentation by 23andMe founder and chief executive Anne Wojcicki during which she presented her company’s plans to do research in areas including Parkinson’s. On March 8, Michael Lee, whose FDABlog advocates less regulation for genetic tests, posted a video pairing Shuren’s comments with Wojcicki’s, and saying that Shuren was being “accused of misleading Congress.” That video is embedded below.
The charge was picked up by researcher-blogger Dan MacArthur at Wired and Duke professor and author Misha Angrist. John Derbyshire, writing for National Review, wrote that Shuren “went for Olympic Gold in bare-faced dishonesty.”Razib Khan at Discover viewed Shuren’s comments as a threat to people’s right to view their own DNA. “If they take our rights away because we’re silent, we have only ourselves to blame,” Khan wrote.
But the FDA says Shuren’s comments were accurate because the research 23andMe published was not medical, but instead related to physical traits like eye color and hair color. (23andMe’s paper is here.)
An FDA spokeswoman writes, “We stand behind the comments made by Dr. Shuren,” She adds: “At that time we were not aware of any of the more than a dozen DTC genetic tests making medical claims that were based on results of a company’s own research. Instead, the companies relied on published research in the literature.” (The full FDA statement is below.)
This statement is true. 23andMe has said it is working on using its data, collected from patient volunteers and customers, to try and understand genetic variants that are linked to disease. One area of interest is Parkinson’s disease; Wojcicki’s husband, Google co-founder Sergey Brin, watched his mother suffer from Parkinson’s and carries a gene that may raise his risk of developing the disease.
In context, Shuren’s quote was clearly about medical research, but he should have made the statement in the past tense. The fact of the matter is the anger about his statement is driven by a larger conflict: the collision between a community of genetics researchers and consumers who see access to one’s own DNA as a fundamental right and the medical community, which sees the tests as medical interventions with risks and benefits.
The main fear of those involved with DNA research is that the FDA will create regulations that prevent people from getting DNA test results without a prescription. There are many arguments that this should not happen. Research shows that people can handle the results from these tests, and it’s not clear that doctors are any more ready to understand them than consumers. Right now, these tests provide only limited information, but the technology for understanding human genetics is advancing at a breakneck pace.
My take remains that we’re set up for a huge clash between traditional medicine and genetics as these two fields, which don’t know how to talk to each other, wind up having to work together more and more often. This spat is merely a prelude.
One piece of advice from those angered by Shuren’s comments is very good: it is past time for those who believe it is important for consumers to be able to access genetic data make their views known to Congress and to the FDA.
The full FDA statement:
The FDA is responsible for reviewing clinical genetic tests. To date, direct-to-consumer genetic tests have not been reviewed by the FDA and as a result, we cannot verify that they provide safe and accurate results. The FDA just concluded an advisory panel with experts representing various aspects of the testing community, which provided us with a set of opinions on several scientific issues in DTC testing. We will review these and other public comments in the weeks ahead to determine what we think is the best path forward for addressing the complex issues related to direct-to-consumer testing products.
We stand behind comments made by Dr. Shuren in a July 2010 Congressional hearing on a GAO investigation into DTC genetic tests made by several companies. At that time we were not aware of any of the more than a dozen DTC genetic tests making medical claims that were based on results of a company’s own research. Instead, the companies relied on published research in the literature.
At a separate 2-day public meeting on laboratory developed tests held by the FDA in 2010, a panel of experts and agency officials, including Dr. Shuren, listened to a brief presentation from 23andMe CEO Ann Wojcicki about her company’s early research efforts. However, most of the described activities, including the one paper they had published, pertained to non-medical claims, such as eye or hair color.
To watch our interview with Congressman Cassidy, click here:
blog.nj.com/njv_guest_blog/2011/03/losst_innovation_may_mean_lost.html
For those with life-threatening diseases or painful chronic conditions, time is not on their side. When promising treatments languish waiting for approval in a bog of bureaucracy, the cost must be reckoned in lost lives and diminished quality of life.
That’s why it’s so alarming that only 21 new drugs gained FDA approval last year. This was a significant decrease from the previous two years— there were 25 approvals in 2009 and 24 in 2008.
Not only are approvals down, so are applications for approval. This portends even further declines in annual approvals down the road. With science more cutting edge today and grants for new research — in areas from pediatrics to Alzheimer’s — at all-time highs, how is it possible that approvals and applications are both dropping?
The FDA’s review process, in the view of many in the medical and biopharmaceutical communities, has become increasingly turgid. The FDA now frequently calls for extra clinical trials, requiring detailed safety plans that necessitate additional doctor and patient education, and an extended review period.
Of the 21 drugs approved in 2010, there were 21 drug makers to take credit. Not a single company earned more than one approval. From Pfizer to Bristol-Myers Squibb to Eli Lilly to Merck — all of which were shut-out for approvals in 2010 — the FDA was an equal opportunity rejecter.
And the problem is not limited to medicines. The development of tools that tailor treatments to our individual needs are drowning in a sea of endless confusion. Tests and medical efforts that can help detect and prevent disease, and eliminate useless or even harmful care are being held up in the name of patient safety.
Government policy writ large has now begun to stifle innovation in pharmaceuticals. Obama’s health care plan levies tens of billions in taxes on new medical products through 2019. Comparative effectiveness studies, required even after FDA approval as a condition for being added to benefits, will delay progress, too.
Even worse is that FDA regulators are beginning to consider the comparative effectiveness of products and as a result are raising the bar for approval.
Sound far-fetched? It isn’t. Consider the case of $8,000-per-month Avastin, an anti-cancer wonder drug that blocks blood flow to tumors. In 2007, the FDA granted accelerated approval for the use of Avastin for treatment of metastatic breast cancer. It was clear from the Avastin studies then that while many women would not benefit from the drug, a significant minority could live longer and with less pain. The FDA asked Avastin researchers to evaluate the drug’s risks and benefits on a larger group of patients with the same standards used to approve the drug in the first place. The study confirmed the 2007 results showing benefit to specific groups of women. But the FDA revoked Avastin’s approval for breast cancer treatment because it didn’t extend life on average.
Innovation is the result, not of a top-down decision, but by learning from actually using an invention. Taking products off the market therefore undermines medical progress in many cases.
As a result of the FDA’s slow-to-act review process, the Obama health care plan’s disproportionate taxation of pharmaceutical firms and this recent Avastin decision, innovation is in a very precarious position. Most medical innovations come from start-ups with limited capital. For all the happy talk about supporting innovation and small businesses, the trifecta of government tactics is doing just the opposite. Just this month, Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, registered his concern: “The question remains whether developers can bring enough new drugs to market at the pace needed to remain financially viable.”
Meanwhile, China, India and Singapore are inviting America’s innovators to set up shop overseas. As the world’s leader — by far — in scientific research investment, the United States must change course and must do so immediately. Not only are we losing innovation, we are losing lives as well.
IMI Shelter
Europe's Innovative Medicines Initiative (IMI) launched eight new projects with a total budget of EUR 172 million ($240.7 million) under a five-year, EUR 2 billion program to relieve bottlenecks in drug discovery and development. The projects are focused on cancer, rheumatoid arthritis (RA) and infectious disease.
In 2009, IMI awarded EUR 246 million to 15 projects involved in improving safety prediction and pharmacovigilance; improving prediction of efficacy in diabetes and brain and respiratory disorders; and education and training in support of medicines development.
A third call for project proposals is under way and will focus on developing treatments for autism, tuberculosis and diabetes, as well as drug and vaccine safety. IMI is a joint undertaking by the EC and the European Federation of Pharmaceutical Industries and Associations (EFPIA) that is similar to FDA's Critical Path initiative.
NICE News
While we do not always agree with him, we are pleased to share the news that our friend and colleague Sir Michael Rawlins has been reappointed Chairman of NICE for an additional one-year term. Rawlins, whose new term runs through March 31, 2012, has served as chairman since the agency was established in 1999.
What Standards Will Apply To Federal Drug ‘Unsales’ Force?
Posted by Cory L. Andrews
Proponents of health care “reform” have invested an enormous amount of time and effort proclaiming how pharmaceutical company sales representatives (colloquially known as “detailers”) and their visits to medical professionals increase the cost of patient treatments and, in turn, health care in general.
For this reason, state and federal regulators have piled on laws and rules dictating what these detailers can and cannot say and do to educate physicians about their products. Some states, most prominently Pennsylvania, have programs where purportedly independent clinicians, pharmacists, and others pay visits to doctors to essentially counter what they hear from drug detailers.
This counter-detailing, or academic detailing, is now poised to move forward at the federal level as a way to circulate government-manufactured “comparative effectiveness” research funded by the 2010 Recovery Act and advanced in ObamaCare. The aim of comparative effectiveness is to reduce health care costs, an especially compelling goal for our government, the number one purchaser of medical treatments in America.
This fact begs the question: can academic detailers, paid by federal taxpayers and distributing federally-funded research be considered unbiased or neutral? And, if that is the case, what safeguards exist to ensure that this federal “unsales” force isn’t sacrificing the highest quality patient care in favor of saving money?
In fact, at this point, no such safeguards exist. Peter Pitts, a former FDA Associate Commissioner who is currently President of the Center for Medicine in the Public Interest, explores this question and puts forward many more important queries in a Washington Examiner op-ed, “What a Difference Two Words Can Make in Health Care.” Those questions include:
* “Will these studies be peer-reviewed before release?”
* “Who will decide what these detailers can say or not say? Will these government “reps” have to play by the same rules as their pharmaceutical counterparts?”
* “If academic detailers stray into off-label conversations, to whom does Food and Drug Administration send a letter?”
* “Who will determine the difference between “communicating” these findings and “promoting” them?”
These are all issues worthy of consideration by those who oversee federal implementation of the health care reform law.
In our interview with the Congressman, we focus on the health care law's impact on the practice of medicine in the long-term and plans by the House of Representatives this year to delay implementation of the law.
Watch the interview here:
As Disraeli said, “The most dangerous way to cross a chasm is in two leaps.”
Lengthy article in today’s edition of the Wall Street Journal (In Health Law, Rx for Trouble) focusing on the many (and immediate) unintended consequences of ObamaCare.
The article’s focus is on the law’s treatment of OTC medicines vis-à-vis flexible spending accounts.
It’s a very lengthy article. What follows are some pieces thereof that relate to the negative impact on physicians.
Sandy Chung is grappling with a new kind of request at her pediatrics office in Fairfax, Va.: prescriptions for aspirin and diaper-rash cream.
Patients are demanding doctors' orders for over-the-counter products because of a provision in the health-care overhaul that slipped past nearly everyone's radar. It says people who want a tax break to buy such items with what's known as flexible-spending accounts need to get a prescription first.
The result is that Americans are visiting their doctors before making a trip to the drugstore, hoping their physician will help them out by writing the prescription. The new requirements create not only an added burden for doctors, but also new complications for retailers and pharmacies.
"It drives up the cost of health care as opposed to reducing it," says Dr. Chung, who rejected much of a 10-item request from a mother of four that included pain relievers and children's cold medicine.
Though the new rules on over-the-counter drugs amount to a small part of the massive overhaul of the health-care system, the unintended side effects show how difficult it can be to predict how such game-changing legislation will play out in the real world.
Some doctors, irked by the paperwork and worried about lawsuits, are balking at writing the new prescriptions. Pharmacists and retailers say the changes mean they have to apply a personalized label on some 15,000 different everyday products for customers paying with certain debit cards.
Health-policy experts predicted that new insurance pools for high-risk patients would attract so many expensive enrollees that funding would be quickly exhausted. In fact, enrollment is running at just 6% of expectations, partly because of high premiums.
A provision preventing insurers from denying coverage to children with pre-existing health conditions prompted insurers in dozens of states to stop selling child-only policies altogether.
Only after the president's signature was dry did the American Medical Association realize what had happened and send a letter to the government warning of unintended consequences, including more office visits and extra paperwork.
Sure enough, when the change took effect Jan. 1, patients began bringing lists of over-the-counter drugs to office visits and also requesting over-the-counter prescriptions by phone, doctors says.
Among those most upset by the changes are pediatricians, who say that small sizes of children's medicines and multiple children per family make the requests particularly burdensome.
"It's an amazingly disruptive policy," says Jesse Hackell, a Pomona, N.Y., pediatrician who is charging $5 to fill such requests via phone. "I am now doing the IRS's work, and that's what I resent most."
After writing two over-the-counter prescriptions free of charge in January, pediatrician Richard Schwartz of Vienna, Va., says he began imposing a $10 surcharge for each prescription, on top of the office co-payment. That is likely to discourage some patients from asking for a prescription, as the surcharge could outweigh the tax savings from using a flexible-spending account.
Doctors are also concerned about malpractice lawsuits, since a prescription potentially puts them on the hook for any problems a patient suffers from over-the-counter drugs.
In the Nielsen survey, 37% of flexible-spending account users said they would ask their doctor about prescription drugs that could replace their over-the-counter medicines.
This is what happens when you look before you leap (translation – when you vote for a bill you have not read).
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.
