NIH

Sen. Grassley: No disclosure, no NIH money

Tracy Staton — Thu, 11 Sep 2008 10:55:12 -0400

Sen. Charles Grassley is at it again. The perennial pharma critic has been knocking university researchers who don't fully disclose their ties to the drug industry--and pushing the National Institutes of Health to police that disclosure. Now Grassley is spurring universities themselves to hand over the info. The Senate Finance Committee sent letters to 20 institutions asking for potential conflicts of interest with drugmakers.

Adding urgency to that call for information was Grassley's own disclosure that a University of Texas researcher hadn't reported $150,000 in speaking fees from GlaxoSmithKline. That researcher, Karen Wagner, had worked on NIH-funded studies of GSK's antidepressant Paxil.

Meanwhile, NIH director Dr. Elias Zerhouni met yesterday with Grassley's committee staff; presumably they hashed over Grassley's calls for NIH to yank funding from universities that don't disclose all payments from pharma. "Starting today, the NIH could send a signal that business as usual is over," Grassley told the Wall Street Journal. "The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure."

- read the Wall Street Journal story
- check out the article in the Washington Post

Avastin-Lucentis trial may reshape pharma

Wed, 14 May 2008 06:59:56 -0400

We thought the head-to-head trial of Avastin and Lucentis for age-related macular degeneration was a big deal for Genentech, which makes both drugs. Now, IMS Health is saying that the trial could be "a Pandora's box" for the entire pharma industry.

Conducted by the National Eye Institute, part of the National Institutes of Health, the trial is designed to see whether the much cheaper Avastin, often used off-label to treat AMD, measures up to the AMD-specific--and very expensive--Lucentis. If Avastin passes muster, then prescribers may desert Lucentis completely. And if docs don't do so voluntarily, then insurers and other payers may nudge, cajole, incentivize, or downright push them to.

And there's the rub, IMS says. By taking the drugmaker out of the testing, this trial could fundamentally reshape relations between payers and pharma. Payers could sponsor comparative drug studies of their own or lobby the government to do so, IMS theorizes, especially as databases make those comparisons easier. There's plenty of time to worry about it, though: The Avastin-Lucentis trial won't wrap till 2010.

- see the story in the Financial Times

ALSO NOTED: FDA panel to mull Celebrex safety for kids; Sanofi makes deal to sell Lilly drug;

Tue, 25 Mar 2008 07:59:50 -0400

> After waiting for nearly a month, officials at the National Institutes of Health alerted some 2,500 people that their names, addresses and detailed personal health information gathered from heart scans in a clinical trial were purloined when an unknown person stole a government laptop with the data on it. Report

> An FDA advisory panel meets today to discuss the safety of several drugs when used in children, including Pfizer's blockbuster painkiller Celebrex, approved to treat kids with rheumatoid arthritis. Report

> Sanofi-Aventis inked a marketing-rights deal with Eli Lilly, allowing it to sell Lilly's tadalafil in the United States. Sales of the drug amounted to $798 million during the first nine months of 2007. Report

> A Wyeth whistleblower lost his wrongful firing lawsuit when a federal appeals court ruled in favor of the drug maker. Report

> On the heels of Cipla's launch of its copycat Tarceva in India, Natco is considering launching its own generic version of Roche's cancer med at a price lower than Cipla's. Report

> Patients who get free drug samples end up with higher out-of-pocket prescription costs than patients who don't, perhaps because the samples lead to a paid prescription to highly marketed, more expensive meds. Report

> Sagent Pharmaceuticals launched its injectable form of Cefepime, a broad spectrum antibiotic that is the copycat form of Elan's Maxipime. Release

> India's Aurobindo Pharma agreed to buy Italian generics maker TAD Italy; it's Aurobindo's third acquisition in Europe. Report

> GlaxoSmithKline consolidated its Cervarix public relations efforts at just one U.K. agency, in advance of the government's decision on whether the vaccine will be chosen for the NHS immunization program. Report

> FDA Commissioner Andy von Eschenbach started a weekly column on the agency's website today, designed to give his point of view on big food and drug news. Report

> The Times of India lauds new efforts in the subcontinent to encourage the growth of its biotech industry. Under new legislation, the country's department of biotechnology is now setting aside 30 percent of its annual budget to fund public/private collaborations on new drug development. Report

And Finally... A daily dose of cod liver oil can cut painkiller use in patients with rheumatoid arthritis. Report

ALSO NOTED: Canadian courts swamped by patent cases; Government to eye small firms for off-label pitches;

Wed, 12 Mar 2008 07:59:50 -0400

> Drug-patent cases are clogging Canadian courts, with some 30 judges assigned to 350 cases that involve highly specialized, technical knowledge. Report

> The government's next target of off-label marketing probes? Small companies, biotech firms, and medical device makers. Report

> China's Aoxing Pharmaceutical inked a deal to buy Shijiazhuang Lerentang Pharmaceutical, which specializes in traditional Chinese medicines for pain management. Aoxing will pay $10.8 million in cash plus 8 million shares of common stock. Report

> India's Nicholas Piramal is eyeing acquisitions in the U.S. and Europe. Report

> Endo Pharmaceuticals named David Holveck as its new president and CEO. Report

> Keryx Biopharmaceuticals' stock price wiped out on the rocky shores of a failed late-stage trial of its lead drug, Sulonex, for diabetes. Report

> EUSA has raised $50M to help fund a Cytogen buyout. Report

> Scientists have used a new computer modeling program supported by the NIH to simulate how a lethal pandemic flu outbreak could hit a modern American city. Report

> Northwestern University scientist Richard Silverman's work led to the blockbuster Lyrica, which translated into more than $700 million in royalties from Pfizer. And his story--told by the Chicago Tribune--illustrates the crucial role that a technology transfer office can play in moving an experimental therapy into the hands of a biopharma company with deep pockets. Report

> The FDA is taking a look at a fresh set of standards that demand new tests to determine if diabetes drugs elevate heart risks. Report

> A group of some of the most prestigious research groups in the country says that five years of flat budgets for the National Institutes of Health is threatening to deter an entire generation of young researchers. Report

And Finally... As drug makers race to develop a FSD drug for women, some psychologists and academics are protesting the "medicalization of women's sexuality." Report

SPOTLIGHT: NIH starts Tykerb vs. Herceptin bout

Fri, 29 Feb 2008 06:59:52 -0500

It's a head-to-head matchup. The National Institutes of Health has launched an 8,000-patient trial pitting GlaxoSmithKline's Tykerb against Genentech's Herceptin in aggressive breast cancer. Meanwhile, GSK is poised to launch its med in the U.K. as Tyverb. Report | Report

NIH launches Avastin-Lucentis trial

Mon, 25 Feb 2008 06:59:57 -0500

Gentlemen (and ladies), start your eye injections. In other Avastin news, the big trial pitting the cancer drug against Genentech sister med Lucentis is now underway. Sponsored by the National Institutes of Health, the independent trial is designed to show how the two meds stack up in treating age-related macular degeneration.

Lucentis has been FDA-approved for use against wet AMD. Though Avastin isn't, eye docs have commonly used it off-label, saying it's almost as effective as Lucentis, if not as effective. And Avastin costs much less: hundreds per treatment versus thousands.

The sticking point has been that, to use Avastin in the eye, it had to be repackaged by compounding pharmacists. Genentech moved last year to restrict supplies to those pharmacies, saying that the FDA was concerned about the repackaging. But Genentech had no plans to study Avastin for macular degeneration, preferring to push its already-approved and more expensive Lucentis.

So the NIH is doing it for them. After all, because macular degeneration tends to be a disease of the elderly, it's Medicare paying for much of the treatment. So the government has a vested interest in proving the cheaper treatment is a viable alternative.

- read the press release from the NIH
- see the story in the Wall Street Journal

Related Articles:
Genentech rethinks Avastin limits. Report
Eye docs confront Genentech exec. Report
Why should Medicare pay for Lucentis? Report
Genentech to curb Avastin sales. Report
Doctors balancing effects, costs of Lucentis and Avastin. Report

Why should Medicare pay for Lucentis?

Mon, 22 Oct 2007 06:59:57 -0400

The U.S. Senate wants to know why Medicare should have to spend millions on Genentech's eye drug Lucentis when the company's Avastin works almost as well against macular degeneration--and costs lots less.

Last week, Genentech said it would cut compounding pharmacists out of the Avastin loop. The move would complicate dispensing the cancer med to macular degeneration patients because compounding pharmacists repackage the cancer drug for ophthalmic use. A vial of Avastin for the eye costs $40 or so, compared with $2,000 for Lucentis.

In a letter to the Center for Medicare and Medicaid Services, a Senate committee demanded to know how much the agency has spent on Lucentis and Avastin. And it wonders whether the center has considered how much it might save by using cheaper, alternative drugs--like Avastin. Meanwhile, the National Institutes of Health is pitting the two drugs against each other in a trial with macular degeneration patients.

- read the the item from the Wall Street Journal's Health Blog

Related Articles:
Genentech to curb Avastin sales. Report
Doctors balancing effects, costs of Lucentis and Avastin. Report
Lucentis gets the green light from regulators. Report
Genentech's Lucentis improves vision in trial. Report

NIH unveils new asthma guidelines

Thu, 30 Aug 2007 06:59:57 -0400

New asthma treatment guidelines could be good news for drug companies. The government advises better day-to-day control of the disease--and that probably means more widespread use of inhaled corticosteroid drugs such as Flovent (GlaxoSmithKline), Azmacort (Sanofi-Aventis), and Pulmicort (AstraZeneca).

For patients with severe asthma, the National Institutes of Health report also recommends Omalizumab, a Genentech/Novartis drug sold under the brand name Xolair, which targets antibodies that can cause asthma symptoms.

- see the new NIH guidelines
- read the Washington Post's take
- and check out this piece on AstraZeneca's asthma drugs

Related Articles:
Scientists find link between colds and asthma attacks. Report
FDA rejects GSK's Advair for COPD. Report
NIH budget cuts cause alarm in research circles. Report