Latest Drugwonks' Blog
Yesterday NRO posted a beside-the-point editorial by Henry Miller who once again recycled his assertion that all the FDA needs is a strong commander who will kick the asses of drug reviewers who fail to approve new medicines as fast as possible.
His attacks have no substance and are actually recycled from news articles written by journalists like Alicia Mundy — who is also a fellow at the Soros funded New America Foundation — and ad homimen attacks from people like Donald Kennedy, the last FDA Commissioner to smoke. Miller dredges up the media invented charge that Gottlieb’s appointment is unusual because he had no medical experience. Miller knows better: Gottlieb still sees patients and has been doing so for years. And Miller’s attacks on Andy von Eschenbach and Janet Woodcock are purely second hand.
Has Henry never heard of surrogate endpoints and biomarkers. And does he really believe that the FDA is fully responsible for the decline in new drug approvals? How about poorly validated targets? How about the fact that companies often withdraw drugs after Phase III? He tosses out a laundry list of FDA problems and ignores the efforts of the three people he attacked to undo them with better science and better oversight. To simply say that only leadership matters is to ignore the fact that scientific change is an important tool for forcing change at the FDA and moving the agency away from being risk averse. Had he had read the Critical Path opportunities list? Does he really think that outdate methods of drug evaluation don’t need to be changed? Is anything going on inside Miler’s mind in this regard beyond chatty assaults?
GlaxoSmithKline has announced that elderly and disabled patients who are eligible for Medicare drug benefits that took effect Jan. 1 will not lose the ability to get free drugs under the company’s patient assistant programs. In December, GSK notified patients eligible for Medicare D that they would not qualify for the free drug programs after May 15.
“The Medicare prescription drug benefit is a valuable program for millions of Americans, but we recognize that there are many elderly and disabled low-income patients who need additional help,” said Chris Viehbacher, GSK’s president of U.S. pharmaceuticals.
GSK plans to ask the federal government for an opinion whether patients enrolled in Medicare D can also participate in patient assistant programs.
For now, eligible patients must opt out of Medicare D to participate in GSK’s free drug programs.
About 200,000 of the 565,000 patients in GSK’s free drug programs are eligible for Medicare D.
Dicey TrOOP implications here. Stay tuned.
Sick patients need access to drugs sooner: US court
Tue May 2, 2006
By Susan Heavey
WASHINGTON (Reuters) — The U.S. Food and Drug Administration’s policy to withhold early-stage experimental drugs from terminally ill patient infringes their right to choose, a U.S. appeals court said on Tuesday, sending the case back to a lower court.
The FDA requires developing drugs to undergo a wide battery of tests, ranging from preclinical testing in the laboratory to large, advanced trials with people. Drug companies say the process can take up to 10 years.
But the U.S. Court of Appeals for the District of Columbia sided with two advocacy groups that filed the suit seeking patient access to new cancer drugs after initial tests show they are safe but before they receive FDA approval.
Judge Judith Rogers, writing for the majority, said terminally ill patients should be allowed to decide whether to accept the risks of taking a medication that might help them live longer.
“The key is the patient’s right to make the decision about her life free from government interference,” she wrote.
The ruling overturns a 2004 dismissal by the U.S. District Court for the District of Columbia, which will now have to review the case unless the FDA appeals.
In the lawsuit, filed in 2003, the Washington Legal Foundation and the Abigail Alliance argue patients have the constitutional right to available treatments.
“If death is certain and you have no options, it’s the individual’s option to decide,” Abigail Alliance President Frank Burroughs told Reuters.
While some patients can take experimental drugs as part of a clinical trial or other programs, he added the lawsuit was critical because many patients are excluded.
The court agreed, saying patients are simply looking for the same access that others have.
In a dissenting opinion, Judge Thomas Griffith sided with the FDA regulatory process, saying government has the duty to ensure that drugs are safe and effective before they are sold.
“Although terminally ill patients desperately need curative treatments, their death can certainly be hastened by the use of a toxic drug,” he wrote.
The FDA has moved to review drugs for cancer and other serious conditions faster than other medicines.
FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb said the agency was “sympathetic” to terminally ill patients and was improving its efforts to make such therapies available.
The Washington Legal Foundation said it was hopeful it could work with the agency to develop a new policy.
In response to my last blog, Jamie Love writes: “1st, the Philippines said it would not import anything until the Pfizer patent expires. 2nd, Pfizer does not have a patent on this drug in the Philippines, so how can anyone in India violate a patent that does not exist? It is not as if the USPTO is the Indian patent office (at least, not yet).”
This misses the point…which is the Philippines bringing in an authorized knock off of Norvasc from India where the Norvasc patent is non-existent. Pfizer as I see it is not defending their patent but trying to stop another end-run around the TRIPS agreement. Let’s stop the guerilla attacks on IP and focus on creative ways to promote partnershps at the pre-knowledge and post-market stages that facilitate drug development and increase access.
Real reform at the FDA is being held hostage to politics. People putting a hold on comfirming Andy von Eschenbach claim a permanent commish is important but that it doesn’t trump politicizing Plan B for the sake of political gain.
In fairness, abortion activists see the Plan B decision — dodged earlier by the FDA — as a line in the sand. They have some science on their side. But some of the same people invoking SCIENCE in defense of Plan B also want to impose an artificially rigid standard on what drugs to approve and want to use the FDA as entity for making one size fits all comparative judgements about medicines when science is moving in the direction of personalized medicine. (That means you Senator Clinton.)
What about this as a principle … the FDA and critics on both sides stop trying to use the agency to engineer social policy and simply approve medicines on the best available evidence. Let people decide and promote the use of better tools and techniques for determining which medicines work best for which people. Let’s do a better job not only developing new medicines but using them when and if appropriate. That’s a responsibility everyone has.
In the meantime, let Plan B free and then let the market, physicians, parents and public health officials make the decisions people on both sides of this issue want the FDA to make. Going forward, let’s put politicians and the media on notice when they use and twist the science of drug development for political purposes. If the medical science supports the use of certain drugs or devices in groups of people, let them on the market and then let’s continue to study how they work and for who. Let’s substitute real science for junk politics when it comes to the FDA once and for all.
From today’s edition of the Washington Post …
No Defense For This Insanity
By Sebastian Mallaby
Team Bush could use some fresh domestic policy. Its talk of tax reform has fizzled. Its defeat on Social Security has destroyed its hopes of fixing entitlements. Its feckless energy non-policy has come back to haunt it. Its tax cuts look ever more untenable as Iraq costs escalate. Its proposed expansion of health savings accounts is incompetently muddled. Its bungling of Hurricane Katrina’s aftermath is legendary. Its trampling of civil liberties has been rolled back by the Supreme Court.
Desperate moments call for desperate remedies. President Bush should seize upon the monstrous Vioxx litigation to champion a cause that he believes in: the cause of tort reform.
Here’s a link to the complete op-ed …
Finally, something we can really pin on the pharmaceutical industry …
Annual deaths in U.S. drop in biggest decline in nearly 70 years
In what appears to be an amazing success for American medicine, preliminary government figures showed that the annual number of deaths in the U.S. dropped by nearly 50,000 in 2004 — the biggest decline in nearly 70 years The government also reported that a baby born in 2004 could expect to live to nearly 78 — an increase of almost half a year from 2003. Women now have a life expectancy of 80.4, up from 80.1. Male life expectancy is 75.2, up from 74.8.
Do I hear a call for Congressional hearing?
Did you see Bill Maher’s naive and unfunny op-ed in yesterday’s LA Times? Just incredulous. Check it out if you’ve got a strong stomach for stupidity and a few minutes to waste.
Here’s the letter I just sent in to the LA Times editorial page in response …
RE: “Pill Popper Nation,” April 27, 2006
To the editor:
So now Bill Maher is a health care expert? His opinion piece was so full of errors and vitriol that I could write a treatise. But I will limit my comments to two of his absurdities. First, he characterizes the Citizen”s Petition submitted by the Coalition for Healthcare Communications as from “the drug lobby.” Not only is this not true, but PhRMA, the industry’s trade association, doesn’t even support it. Maher writes that the petition wants to “get rid of the warnings in drug ads.” Also wrong. The petition (which I helped to draft) calls for more user-friendly warnings. After all, warnings that people don’t understand don’t help advance the public health. But what really got my dander up was Mr. Maher’s libelous and mean comment that all the FDA does is “protect the profits of pharmaceutical companies.” This is an unfair, unearned, and unjust attack on the 10,000 overworked, underpaid —and exceptionally devoted staff of the FDA. When it comes to health care, Maher is less.
Peter J. Pitts
Pitts is Director of the Center for Medicine in the Public Interest and a former Associate Commissioner at the FDA
When I was at the FDA and we announced a new draft guidance on DTC print advertising, Dr. McClellan commented that when it came to the brief summary “less may indeed be more.”
Today the agency is calling for more research into this issue — but solid metrics already exist. Right now, as we speak, the FDA possesses a broad body of high quality research that has been conducted on the brief summary — with protocols reviewed and commented on by the folks at DDMAC.
The news item below is all well and good — but calling for more research is a poor excuse for lack of action on this important public health issue.
(FYI — Inside the agency the brief summary is often derided as being like the Holy Roman Empire — it is neither brief nor a summary).
FDA Will Survey Consumers on Brief Summary
The FDA plans to survey consumers on the content and format of the brief summary in direct-to-consumer ads, according to an advance Federal Register notice released April 24. “In recent years, FDA has become concerned about the adequacy of the brief summary in DTC print advertisements” because the detailed, technical prescription drug information geared toward physicians increasingly was used in ads for the public as a way for advertisers to fulfill the vague brief summary requirements, the notice states.
The FDA plans to investigate the role of context in providing useful information to consumers, such as comparing consumer perceptions after viewing mock ads with risk information in chart or paragraph form. The agency also will study whether listing side effects and placebo rates of occurrence influences perception. Additionally, the FDA will survey the effectiveness of brief summary information provided in question-and-answer, highlights and drug facts formats. The agency will accept comments for 60 days after publication in the Federal Register under docket number 2006N-0133.
An unpublished letter by drugwonks commentator Ben Zycher. A loss to Washington Post readers — but a drugwonks.com bonus!
To the Editor of the Washington Post,
Shankar Vedantum’s article (“Comparison of Schizophrenia Drugs Often Favors Firm Funding Study,” April 12) misses the central reason that comparative drug tests funded by a given pharmaceutical producer usually report superiority for that producer’s drugs. The research and development process for new drugs aims to improve upon the clinical experience of existing treatments, which always are weak for some patients and for some of the many dimensions of such disorders as schizophrenia. To the extent that the research and development process is successful, studies conducted to determine whether or not the new treatments offer improvement for some patients in terms of some symptoms will find, quite honestly, that they do indeed.
Moreover, no advertising or promotion of such new drugs may proceed until the data are reviewed and approved by the FDA. And the argument of some that studies funded by government systematically will yield unbiased comparisons is incorrect: The government has powerful incentives to promote certain (older) drugs, the use of which will reduce budget pressures. Pharmaceutical producers have profit incentives not to mislead themselves, and doctors and patients have strong reasons to find the most effective treatments.