Latest Drugwonks' Blog
A new study from BIO and BioMedTracker reports that the success rate in bringing new medicines to market in recent years is only about half of what it had been previously, but biotech drugs are twice as likely to gain U.S. approval than more traditional chemical drugs, according to a new study released on Monday.
The study, covering 2004 through 2010, found the overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10, down from one in five to one in six seen in reports involving earlier years.
Adding weight to the desire by major pharmaceutical companies to become increasingly involved in biotechnology was a finding that biologics had a 15 percent chance of going from Phase I through to FDA approval, compared with a 7 percent success rate for traditional small molecule chemical drugs.
Well – nobody said innovation was easy. But wait – it gets worse.
After saying that he wanted America to embrace innovation – President Obama is trying to make it more difficult, specifically when it comes to the desire to invest in pharmaceutical innovation – a sure bet under no circumstances.
The President’s proposed 2012 budget blueprint seeks to hasten availability of biosimilars by cutting the market exclusivity of innovators from 12 years to seven.
Bad idea since a longer period of exclusivity funds an innovator company’s research and development efforts.
12 years of exclusivity also gives hope to those suffering from rare diseases or conditions. If innovator companies think they will have a short time before a follow-on versions of their products hit on the market, they will likely only focus on drugs for major diseases and conditions -- potentially ignoring ailments that are less common, but equally as serious, to those suffering.
If innovation is one of the key answers to our national economic recovery, then the President should abide by what he said, “Our economy is not a zero-sum game. Regulations do have costs; often, as a country, we have to make tough decisions about whether those costs are necessary. But what is clear is that we can strike the right balance. We can make our economy stronger and more competitive, while meeting our fundamental responsibilities to one another.”
I know the answer! The answer lies within the heart of all mankind! The answer is twelve? I think I’m in the wrong building.
-- Charles Schulz
The Right Prescription
Obamacare's Sales Force
House Republicans plan to cut $360 million in Obamacare funding in this year's budget. That's a good start, enough to slow implementation of the health care law but not stop it. But not good enough to stop the administration from spending $100 million to run an ad campaign and hire a sales team to push Obamacare to thousands of doctors. That's right. Obamacare will use a sales force (with cars and expense accounts) to convince doctors that government health guidelines are the way to go.
The home of this marketing machine is Agency for Healthcare Research and Quality (AHRQ). Its budget of nearly $1 billion a year (starting in 2014 it will be more) is scheduled to be cut by only $25 million this fiscal year. Perhaps Republicans don't know that AHRQ is the operating system for Obamacare as well as its campaign manager.
AHRQ is mentioned in the Obamacare law 12 times. The agency and its consultants -- most of them true Obamacare believers -- are responsible for determining what preventive services we get, what health care "quality" is, what should be cut from Medicare and what new technologies should be paid for.
AHRQ was behind the decision to restrict breast exams to women over 50. It supplied the "evidence" for annual end of life counseling for the same seniors it decided shouldn't get screened for depression or hip fractures. Meanwhile, it's funding radical organizations pushing for sex change operations and the autism-vaccine link.
And it has big plans for the rest of that money. The Obama administration is not content to control what doctors do. It wants to control what they know as well. Carolyn Clancy, AHRQ's director, talks about "embedding" directives, guidelines, and reminders into the electronic health records of every American. AHRQ is spending millions to insert clinical decision support tools for a variety of purposes. One of the most prominently mentioned: end of life care counseling.
But AHRQ is not just content to "embed" Obamacontent into the lives of every American. It is also spending $50 million to "build a marketing campaign around comparative effectiveness research. (CER)." CER is promoted as information about what are the most medically and cost-effective treatments, drugs, and medical devices. But what works and what doesn't can change almost daily and varies by individual. Simple blood tests and iPad-equipped sensors will be able to monitor many illnesses before they spread as well as individualize treatment of a disease.
AHRQ is not only spending hundreds of millions of dollars on studies claiming there's insufficient evidence to either use or pay for such technologies.
AHRQ is spending millions to insure that its information is found more quickly and more often on the Internet. Over 70 percent of all Americans use the Web to seek out medical information. AHRQ plans to crowd out other sources of advice by making sure Obamacontent is embedded in as many websites as possible and using search engine tools to drive doctors and patients to government friendly or supported sites.
AHRQ is spending $34 million for an ad campaign to get doctors to adopt comparative effectiveness research. Here too, the campaign is heavy on Web-based tools with the goal of trying to get AHRQ and its consultants positioned as "experts" on Twitter, Facebook, YouTube, and search engines. It is buying up ad space in medical journals, which AHRQ is also flooding with its studies claiming most new technologies are more effective than old ones.
In case doctors don't get the message "embedded" in health records and the Internet, AHRQ is hiring hundreds of Obamacare sales reps to convince physicians that Obamacare medicine is the way to go. AHRQ's Obamareps will be paid $20 million to sell doctors AHRQ prescriptions. For instance, AHRQ reps will tell doctors that that all diabetes, hypertension, and prostate cancer treatments are more or less the same, often using data a decade old.
Medical science is way ahead of AHRQ. Doctors are able to tailor treatments to the race, gender, age, family history of a patient, as well as the pathways many forms of cancer takes. Today new imaging technologies and genetic tests can help predict cancer risk. But AHRQ's sales reps will tell doctors there's no evidence they save lives.
Obamacare 's overlords want to monopolize medical decisions and medical information while marginalizing everything else. That goal is central to setting up the health exchanges and limiting choice. AHRQ's multi-million marketing campaign is critical to both. Unless Congress cuts it budget to nearly nothing, it will be impossible to repeal the law and replace it with something better.
Yesterday the FDA held a “stakeholders” call to discuss the agency’s FY 2012 budget. Specific information will be shortly posted on the FDA website.
After a brief intro by Commissioner Hamburg, the heavy lifting was done by Patrick McGarey, Director, Office of the Budget.
Two items of particular note:
1- Within the 2012 budget is an allocation for $25 million for “advancing regulatory science.” (In fact, the Commissioner made specific note of the need for this in her opening remarks.) During the Q&A session, I asked what non-user fee monies were being allocated to the Reagan/Udall Center (RUC). The answer was, “none.”
That’s both disappointing and surprising since the (still not approved) fiscal 2011 FDA budget included $25 million for “scientific modernization under the Advancing Regulatory Science Initiative (ARSI). ARSI, as it was described at the time (February 2010), is a cross-center program whose ultimate objective is to provide FDA scientists with the skills to evaluate the safety, effectiveness and quality of products developed with new and emerging technologies, as well as give industry the standards by which such products will be judged.
Included in the 2011 budget for ARSI was $4.45 million in funding for the Critical Path Initiative. Why was that allocation zeroed-out? And all of this assuming the President gets full funding for his budgetary requests – which is not likely.
2- Mr. McGarey mentioned that the agency was working to develop a pathway for biosimilars that would be used “after the innovator’s patent had expired.” I asked if that meant that the agency had decided that the legislation that created a framework for such a pathway was based on patent life or data exclusivity. His answer, “I can answer with 100% certainty that that isn’t a budget question.” I hope that means he misspoke.
Lack of money is the root of all evil.
-- George Bernard Shaw
It was “give ‘em hell” Harry Truman who said, “Give me a one-handed economist. All my economists say on the other hand …”
Alas, when it comes to healthcare economics, it seems that “the other hand” is a focus (or rather a lack thereof) on patient care.
Consider this new press release:
DestinationRx Tools Yield $1 Billion in Savings on Prescription Drugs in 2010
Utilization of low-cost alternative reports leads to significant annual savings
LOS ANGELES--(BUSINESS WIRE)--DestinationRx, Inc., a leading provider of health plan and drug comparison tools, technology and data, today released data showing the substantial savings offered by the Company’s Drug Compare suite of online prescription drug comparison tools. An analysis of user activity in 2010 shows that the DestinationRx tools yielded an estimated $1 billion in savings for users, with a total of $13 billion in potential savings had all users acted on Drug Compare information.
According to a company spokesperson, “We hope to see even more success in 2011 as we expand and improve our tools to better serve Drug Compare users.”
Now that depends on who your "users" are, doesn't it?
On the one hand, by switching patients to less costly medicines that may not be as effective, money is indeed saved by payers – at least in the short term. But, on the other hand, what about the many metrics that demonstrate how switching patients for cost rather than therapeutic reasons results in poorer outcomes and increased costs in non-pharmaceutical interventions?
And isn’t the best patient outcome the desired … destination?
Ignorant men don’t know what good they hold in their hands until after they’ve flung it away.
-- Sophocles
Isn’t it about time that CDRH is renamed the Center for Medical Technology?
The U.S. Food and Drug Administration has proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly.
For the complete FDA announcement, see here.
"We do what we must, and call it by the best names."
-- Ralph Waldo Emerson
I've got a little list, I've got a little list
Of healthcare regulators who PDUFA doth confound
With deadlines often dissed, they never would be missed.
I believe it was former US Senator, Everett Dirkson who first said, “When I feel the heat I see the light.”
Now it’s time for folks at the FDA to repeat it. Repeat it, in fact, as a mantra.
As you’ve surely heard, House Approps has FDA on its little list of cuts to 70 accounts that will be included in the CR. And included on that list is a $220 million cut to FDA. (The list does not specify how those cuts are to be allocated but, if enacted, would be implemented over the final seven months of the current fiscal year - -which ends on March 4th.)
The general sense is that the Appropriations Committee will not hold a markup, rather the bill is expected to be brought to the floor next week under an open rule. That means the number of amendments to be filed could reach into the thousands, so where things end up is anybody’s guess.
What is pretty clear is that FDA is, indeed and as predicted, in the Congressional crosshairs.
Repeat after me, “When I feel the heat I see the light. Om.”
Remember, that $220 million won’t come from PDUFA fees but rather from that piece of the FDA budget largely allocated for staff and school supplies. And there’s no fat there. None. (Note: Despite the dearth of new obesity medications, this is most certainly NOT a good thing. Indeed – it is a dangerous thing. Very.)
But this proposed cut is, in many ways, tied to the PDUFA debate. The current deliberation surrounding PDUFA reauthorization, at its core, is a discussion of first principles – of predictability, consistency, transparency, and cooperation.
When I feel the heat, I see the light.
Perhaps the best way for the FDA to counter the very unfair and perilous call for bone-deep budget cuts is for FDA Commissioner Hamburg to raise go in front of the committee, raise her right hand and say, “I want a more accountable FDA.”
But shouldn't more money be tied to what my colleague Peter Pitts calls for: "responsible and predictable behavior on the FDA's part?"
We have heard the complaint that FDA is under-funded for decades. But all bureaucracies say that if they had more money, they could do more. The question is, what is FDA doing with the money they have. Or as Lincoln once observed: "Be what you are. But be a good one."
The FDA is spending way too much time and money on regulatory science that does nothing to encourage the use of biomarkers in clinical trials.
Instead of following the critical path, it is more inclined to apply the precautionary principle to product approvals.
By framing its decisions on relative risk it has raised the bar for product approval in ways that make even helpful products unavailable. And by shifting standards for post market review of drugs like Avastin it demonstrates that it cannot always be trusted with the money it has...
The FDA should show how it will get back on the track it was taking before Vioxx before it asks for money. It should show it will be something different, not a smaller version of what it currently is.
Or as Steve Martin put it: A day without sunshine is like, you know, night.
Virginia Heffernan’s article (Prescription for Fear www.nytimes.com/2011/02/06/magazine/06FOB-Medium-t.html) claims WebMD is a less trustworthy health info than Mayo because it (in her words) shills for drug companies.
She should be less concerned about drug advertising and more about how online health sites are used to shape public perception. If she did, she would have focused on all the sites that spread anti-vaccine fear. Most of them are not in it for the money. Those that are hawking their own products.
Moreover, she ignored how mainstream coverage, relying on such sources, spread panic and misinformation. The media perpetuated the anti-vaccine ideology, overstated the risks of anti-depressants and recently called a 1 in 3 million occurrence of a rare lymphoma in women with breast implants a “link.”
Ms. Heffernan is right to be wary about many online health sites. But her concern with WebMD is misplaced. WebMD’s medical reporting copies other news outlets. She should have focused on her own industry’s mangling of medical information.
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.
