Tag: "FDA"

The FDA Cannot Handle Personalized Medicine

The current regime was built during a time of pervasive ignorance when the best we could do was throw a drug and a placebo against a randomized population and then count noses. Randomized controlled trials are critical, of course, but in a world of limited resources they fail when confronted by the curse of dimensionality. Patients are heterogeneous and so are diseases. Each patient is a unique, dynamic system and at the molecular level diseases are heterogeneous even when symptoms are not. In just the last few years we have expanded breast cancer into first four and now ten different types of cancer and the subdivision is likely to continue as knowledge expands. Match heterogeneous patients against heterogeneous diseases and the result is a high dimension system that cannot be well navigated with expensive, randomized controlled trials. As a result, the FDA ends up throwing out many drugs that could do good.

Alex Tabarrok on Peter Huber. See our previous posts on personalized medicine here and here.

Jun 12, 2013 | 11 comments | by

Why Don’t We Have Drug Approval Reciprocity?

If the United States and, say, Great Britain had drug-approval reciprocity, then drugs approved in Britain would gain immediate approval in the United States, and drugs approved in the United States would gain immediate approval in Great Britain. Some countries such as Australia and New Zealand already take into account U.S. approvals when making their own approval decisions. The U.S. government should establish reciprocity with countries that have a proven record of approving safe drugs — including most west European countries, Canada, Japan, and Australia. Such an arrangement would reduce delay and eliminate duplication and wasted resources. By relieving itself of having to review drugs already approved in partner countries, the FDA could review and investigate NDAs more quickly and thoroughly.

Dan Klein and Alex Tabarrok here and more here.

Jun 05, 2013 | 15 comments | by

How Medicare Wastes Money

Genentech…makes an anti-cancer drug called Avastin. It also makes Lucentis, a closely related drug that is used to treat macular degeneration. Both drugs work equally well for macular degeneration, but Lucentis, which is FDA approved for this condition, costs $2,000 a dose compared with $50 for the same amount of Avastin. The FDA can’t approve Avastin for macular degeneration unless the company requests it, and Genentech has no financial interest in doing so. This leaves Medicare with no choice but to pay top dollar for Lucentis. Other than to save their patients money, doctors have no incentive to prescribe Avastin, even though they can do so “off label.” The difference in price costs Medicare, and taxpayers, hundreds of millions of dollars a year.

And because Medicare beneficiaries must absorb one-fifth of the cost of each treatment, Lucentis costs the patient $400 a dose, compared with $11 for Avastin. Medicare can do nothing about it…

Medicare can’t require proof that an expensive new product is any better than the one it’s replacing; it’s explicitly prevented from doing so by law. Medicare can’t even encourage patients and doctors to select a less-expensive option that works just as well. With few exceptions, neither CMS nor the Food and Drug Administration can take a new product’s price or its performance into consideration when making coverage decisions. And once Medicare starts writing checks, private health plans generally fall into line.

More from Art Kellermann at RAND.

Apr 05, 2013 | 13 comments | by

Why Cancer Care Costs So Much

Oncologists typically make more money if they use newly approved drugs and the latest radiation treatments than if they use cheaper, older alternatives that work just as well. (This is because they get paid back the cost of the drug, in addition to an extra 6 percent of that cost — the more expensive the drug, the higher the compensation.)

Some of these new therapies are rightly heralded as substantial advances, but others provide only marginal benefit. Of the 13 anticancer drugs the Food and Drug Administration approved in 2012, only one may extend life by more than a median of six months. Two extended life for only four to six weeks. All cost more than $5,900 per month of treatment.

Source: The New York Times.

Apr 04, 2013 | 11 comments | by

Pay for Delay

The big pharmaceutical with a blockbuster drug gets to have the only product on the market for a little longer. It also doesn’t have to deal with price competition. The FDA estimates generics usually cost 80 to 85 percent less than brand-name drugs — not great news for the maker of the brand-name medication.

As for the generic drug maker, it has to hold off on coming into a given market — but it also gets a settlement from a pharmaceutical, often in the millions. Not a shabby deal either.

The Federal Trade Commission, which brought the suit, has a completely different take. It argues that this is horrible for consumers, who end up with higher drug prices as generics stay off the market longer than they otherwise would. With more than a dozen pay-for-delay deals struck annually, the FTC estimates that these settlements will cost consumers $35 billion.

More from Sarah Kliff.

Mar 29, 2013 | 14 comments | by

Increased Medicare Costs Due To Aging, and Other Links

Nearly three-quarters of the spending increases in Medicare over the next two decades can be attributed to aging alone. HT: Arnold Kling.

Miracles happen: The FDA decides to err on the side of drug approval.

Latvian PM to Krugman: By ignoring your advice we became the fastest growing economy in Europe.

Mar 18, 2013 | 12 comments | by

Headlines I Wish I Hadn’t Seen

The liberals’ war on science.

Sex in space may be bad for your health.

AquaBounty first applied to the FDA for approval to sell salmon, genetically engineered to grow twice as fast as normal salmon, in 1993; to this day the FDA is still soliciting comments.

Mar 18, 2013 | 10 comments | by

Lack of Sleep Affects Genes, and Other Links

Lack of sleep mars genes.

Hiring only healthy employees beats managed care every day of the week.

Does the F.D.A. have the authority to make smoking nonaddictive?

Most people like the idea of virtual medicine.

Mar 13, 2013 | 10 comments | by

Heart Disease Common in Historic Times, and Other Links

137 mummies from four cultures spanning 4,000 years challenge the widely held assumption that cardiovascular disease is largely a malady of current times.

Internet better than FDA for alerts to drug side effects.

Do animals get all the same diseases as humans?

Mar 11, 2013 | 12 comments | by

Robots in Hospitals

The FDA approved the country’s first human-interacting autonomous robot for hospitals on Thursday. The RP-VITA, made by iRobot (best known to consumers as the makers of the Roomba) and InTouch Health, is a human-sized telepresence robot which allows doctors to remotely interact with hospital patients. The robot can navigate hospital corridors autonomously, while medical professionals talk and interact with patients through a special iPad app.

Article with photo. HT: Tyler Cowen.

Jan 25, 2013 | 9 comments | by
Next Page »