This decision could represent a major shift in standards for assessing the effectiveness of cancer meds. In granting approval, the FDA rejected the recommendation of its advisory panel, which last December voted 5-4 against the drug, because the benefit in slowing tumor growth wasn’t believed to be worth the added risk of serious side effects, including high blood pressure and death.

At issue was whether slowing tumor growth - known as progfession-free survival - for an additional 5-1/2 months in metastatic breast cancer merits approval, even though Avastin wasn’t shown to extend life. The question, of course, resonates far beyond any one drug as the agency grapples with increasingly vocal cancer patients and their advocates, who insist any benefit is important.

For drugmakers, the approval is an important signal, because it can be expensive to conduct the lengthy trials needed to prove a drug can extend life. The approval also bolsters an industry tactic called label expansion, which is used to squeeze additional revenue out of a medication. In the case of Avastin, which is already approved to treat colon and lung cancer, Genentech may reap an additional $1.3 billion a year in revenue.

“We felt this is an effective drug for breast cancer,” Richard Pazdur, director of the agency’s Office of Oncology Drugs, tells Bloomberg News, adding that the FDA still believes survival is the “gold standard” for cancer drugs, and if further Avastin studies don’t demonstrate a benefit, the agency may require another advisory panel.

The FDA’s decision may now open the door for other cancer meds to be approved if studies find the meds can shrink tumors, although some docs worry patients may not really benefit. “If FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint,” Kay Dickersin, director of the Center for Clinical Trials at Johns Hopkins University, tells the Associated Press.

“The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, today’s decision is a victory for drug companies, but not for patients,” Breast Cancer Action executive director Barbara Brenner says in a statement headlined ‘Patients Lose, Genentech Wins.’

Another patient advocate disagrees. “The benefits we’re looking at with Avastin matter because they give patients hope,” Margaret Kirk, president of Y-Me Breast Cancer Organization. “Without disease progression they may survive to see a discovery that can help them in the future.” But what do you think?

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In a letter to Congress, he says the agency lacks “explicit jurisdiction” in other countries hampers its ability to inspect facilities and investigate manufacturers that violate US laws. And Leavitt called for legislation to give the FDA jurisdiction abroad. The letter was sent to Republicans on the House Committee on Energy and Commerce, Bloomberg News reports.

“Current law has not kept up to date with modern technology and global marketing realities,” Leavitt wrote in his letter, which was sent to Republicans Joe Barton of Texas and John Shimkus of Illinois. “An amendment would better enable FDA to address criminal conduct that occurs entirely outside of the United States and threatens the health and safety of consumers within the United States.”

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That’s the question Bob Ehrlich, a former Warner-Lambert exec who now runs a consulting firm, mulls over in his weekly blog. In his view, the odds are against a big change in the use of mass media. For the moment, he ballparks the odds on a momentous shift at only 30 percent. But he doesn’t take much comfort in the age-old defense that the First Amendment will preserve DTC. And lobbyists won’t save the day, either. Here’s why…

“What if a ‘change’ election occurs, as seems entirely likely? With a likely expansion in Americans covered by health insurance and the resulting costs to do so, what changes might occur to limit cost increases? Hmm, let me think! Drug costs will be a key component. Drug marketing affects cost by emphasizing newer and more expensive drugs. So a scenario that greatly limits drug company marketing is entirely possible,” he writes.

“Free-speech issues are going to limit how draconian regulation could be. That does not mean government will not be able to restrict marketing. Courts will allow reasonable regulation to protect public health. A tweak here or there could make it much harder for drug companies to use mass media. Congress could also go after how drugs are detailed.

“Do I really think mass media is going to end? I would say it is 70 percent likely it will stay pretty much as is for the next few years. If Obama wins, he may succeed in his goal of greatly expanding medical coverage by the end of his first term. If that happens then I would place the odds of greater restrictive change at 50 percent or higher. After all, we have only had easy-to-do mass DTC for 11 years, so going back to pre-1997 is not a stretch in scenario planning. I would hate to see an end to mass media DTC, but thinking that first amendment protection guarantees it long term is a mistake.”

Hat tip to the WSJ Health blog

Not as much as you might expect, given double-digit increases in recent years, yes? And that’s the same paltry growth rate as the overall prescription drug market, according to The RPM Report, which cites IMS Health data that was previewed at a recent industry conference.

What does this mean? The generics biz is getting more competitive as more players fight for share in the primary-care market, which reduces prices. As a result, according to Diana Conmy, IMS Health’s corporate director of market insights, the second half of last year saw a “tremendous reduction” in the price of generics without a corresponding increase in volume levels.

This may explain more so-called ‘at risk’ launches, in which a generic maker debuts a copycat version before patent litigation has been resolved. Teva, for instance, created a stir with its recent launch of a generic version of Wyeth’s Protonix. “The generic erosion curves are much steeper,” she said.

The bottom line - growth is coming from new approvals, and brand-name drugmakers are holding onto dollar share even as generic use increases.

Hat tip to The RPM Report (subscription may be required)

David Snow may be a Republican, but he knows when legislation is in his best interest. And efforts by Democrats to make biogenerics a reality and to create a safety net for millions of uninsured Americans will mean more business for Medco Health Solutions, the pharmacy benefits manager that he runs. Dave doesn’t say who’ll win his vote in the upcoming election, but he does sound happy in an interview with The Star-Ledger of New Jersey (which owns Pharmalot). Here is an excerpt…

SL: Wal-Mart could be moving into the pharmacy-benefits business. Are you worried?
Snow: A lot of people shake in their boots when they hear the name Wal-Mart in any industry. This is a very, very complicated business with serious barriers to entry. I just don’t think they’re going to pull it off. You just don’t snap your fingers and say you’re going to be a pharmacy-benefits manager.

SL: Why are generic drugs so good for Medco’s business?
Snow: We make our money on generics, because by doing that, we are completely aligned with the best interests of our clients. We do not make money on branded drugs at our mail pharmacies. We make zero dollars. However, 84 percent of the drugs going through those mail facilities are branded drugs. Since 2006, enormous volumes of branded drugs have gone off patent with generic availability. Both 2006 and 2007 were fantastic years for branded drugs going generic. There is still about $80 billion worth of branded drugs scheduled to go off patent between now and 2015.

Sixty-three percent of all scrips are generic now - only 37 percent are brand. From a client’s perspective, from the person who pays the bills perspective, only 16 percent of the dollars are generic. The rest represents 84 percent of the payer’s expense. We try as best we can - and we’re very good - at appropriately moving from brand to generic. I could make money on those brands, but I choose to make it on generics, so there’s no question about my line of sight with my clients. If I’m incented to move brands, my client’s got to say, “My God, are you serving my best interest?”

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The state Attorney General, Mike McGrath, filed a lawsuit in state court claiming that AstraZeneca and Johnson & Johnson’s Janssen unit for making and marketing antipsychotic meds that are “in defective condition and unreasonably dangerous,” The Helena Independent Record reports. He’s referring, of course, to Seroquel and Risperdal.

McGrath charged the drugmakers “have engaged in false and misleading marketing, advertising and sales campaigns to promote these drugs for non-medically indicated uses.” McGrath said the companies “successfully deceived physicians, citizen-users and others in the medical community” about the safety of these drugs compared to other antipsychotics in order to carve out a greater market share.

This false promotion of these two atypical antipsychotic drugs have led to some Montanans who faced “serious injuries, illnesses, diseases or death,” McGrath charged, adding that the drugmakers illegally marketed and promoted Risperdal and Seroquel for uses not approved by the FDA, including treatment of dementia, sleep disorders, depression, attention deficit disorder, autism, depression, mood disorders and others.

A national coalition of about 30 state attorneys general is involved in a similar investigation of antipsychotic drug marketing, although not every state is participating in the effort. Arkansas, for instance, filed its own lawsuit concerning Risperdal.

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In a blistering editorial in Science magazine, editor-in-chief Donald Kennedy notes that Pfizer has issued subpoenas to the New England Journal of Medicine in order to wade through confidential reviews of published studies of its Celebrex and Bextra painkillers, which are the subject of numerous product-liability lawsuits. As he sees it, Pfizer wants it both ways - an opportunity to defend itself against litigation that involves dismissing the same confidential system that validates industry research. To Kennedy, it’s a ‘fishing expedition’ that will undermine journal integrity.

“At Science, we editors love our reviewers and know that our editorial colleagues elsewhere do, too. After all, the process of scientific publication depends on the volunteer services of thousands of experts all over the world who willingly provide, without compensation, confidential and candid evaluations of the work of others. Because all of us in scientific publishing depend on reviewers, we’d better try to keep them at it, happy, and secure. But the following case, involving a lawsuit, a drug company, and the company’s assault on the confidential files of a journal, is a bad news story.

“The drug company Pfizer is being sued in various jurisdictions on product liability grounds. Plaintiffs are claiming that its products Celebrex and Bextra cause cardiovascular and other injuries. Pfizer asserts that in some cases plaintiffs are making use of published papers from the New England Journal of Medicine. So it wants to dig through the confidential reviews of those papers in search of something to strengthen its defense. The company served NEJM with a series of subpoenas to which the journal replied, claiming several privileges in support of its refusal to comply.

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Amid global calls to end pharma’s direct sponsorship of physician education, the British Medical Journal writes about an investigation by the Australian Broadcasting Corporation that found industry sponsorship of sessions attended by thousands of general practitioners, who assume the programs are totally independent.

Industry representatives have confirmed that similar practices take place in the UK, where roughly half of all education for doctors is sponsored by drugmakers, writes Ray Moynihan, honorary lecturer at the University of Newcastle in Australia. He describes leaked documents and e-mails from a range of sources showing pharma sponsors have input into the selection of some speakers at seminars held in recent years, despite the fact that these have been aggressively sold to general practitioners in brochures claiming that “all content is independent of industry influence.”

The industry trade group, Medicines Australia, confirmed the practice of inviting input from sponsors into the selection of speakers is by no means uncommon, while the view from the industry is that allowing sponsors to suggest speakers does not compromise the independence of medical education, as the educational providers have ultimate control over who speaks.

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs being announced each month. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone?

Wyeth Consumer Healthcare named Isma Benattia exec vp, global R&D;
AstraZeneca named Jean-Philippe Courtois as a non-executive director;
Lilly added Michael Eskew, former United Parcel Service ceo, to its board;
Shasun Chemicals & Drugs appointed Norbert Dieterich president of its UK subsidiary;
WeissComm Partners hired Tom Jones, formerly with Novartis, as managing director;
Novo Nordisk named Pam Harris vp for diabetes sales, managed care and government accounts.