A surfeit of information

August 7, 2008 – 2:07 pm

There were some interesting bits of news over the past seven days to chew over. The U.S. Preventive Services Task Force recommended against routine prostate cancer screening for men over 75; FDA has strengthened its management of FDA advisory committees; members of Congress want Dr. Richard Peto’s analysis of the SEAS data; drug maker Eli Lilly and Co. has sold its Greenfield Laboratories R&D facility to the CRO Covance; and the U.K.’s NICE has rejected four kidney cancer drugs for use by the National Health Service. In addition to the news, the bloggers continued to stir their own pots, offering up a feast of commentary about sundry other topics. Who said the summertime was easy?

For kidney cancer patients, NICE anything but

If you live in the United Kingdom and have advanced and/or metastatic renal cell carcinoma, you won’t get access to Avastin, Nexavar, or Torisel. Ed Silverman at Pharmalot writes about the news here; Jacob Goldstein at the Wall Street Journal Health Blog has his write-up here.

Of course, Peter Pitts at DrugWonks was ready and waiting to blast the decision. “Doctors don’t have a lot to offer people with advanced kidney cancer,” he says. “If these drugs can help them - and the clinical trials show that they do - shouldn’t they be made available?”

He links to the Daily Mail story that called the decision “a devastating death sentence for kidney cancer patients,” and the press release from Cancer Research UK. Mr. Pitts also cites his London correspondent, Antoine Clarke: “”It means that a rare disease will be neglected by the NHS, in a brutal reversal of the complaint made about poor countries where diseases are untreatable because of a lack of available drugs. Here the research has been done, clinical efficacy demonstrated by the ‘greedy’ drugmakers, but no one will get the medicines because the UK government has decided not enough people die of the disease: ‘only’ 3,600 people out of the 7,000 who are stricken by metastatic renal cell carcinoma. And if you dare buy it out of your own pocket, you will be denied ANY treatment by the NHS, including emergency care, but still have to pay for it in national insurance taxes. Welcome to universal healthcare! America’s tort lawyers will love it!’

Comparative effectiveness: the debate continues

Meanwhile in the United States, the Senate introduced a bill to establish an institute to review the effectiveness of drugs, devices, and medical procedures to cut health-care costs. Mr. Silverman reviews the news here. The Pharmaceutical Care Management Association has endorsed the bill.

Maggie Mahar at the Health Beat Blog has her own take on the news, and worries about the composition of the task force: “Pharmaceutical and device companies should not have a seat at the table. Their financial self-interest (which would lead them to favor the most expensive products) creates an immediate conflict of interest. They should be consulted; but they should not have a vote.”

Dr. Roy M. Poses at Healthcare Renewal agrees with Ms. Mahar. “Because of these conflicts of interest, neither representatives of private payers nor representatives of pharmaceutical, biotechnology or device companies should be on the board of this institute,” he says.

Ms. Mahar gets even more specific about why pharma companies should not be involved in comparative effectiveness research in this post here, in which she picks apart a CommonHealth study of patient/physician interaction. “It’s one thing to claim that a drug works when it doesn’t, but there’s something especially weird about insisting that advertising can — and should — effectively structure patient-physician interactions,” she says. “This point is all the more perverse because the same organization that’s saying marketers should mold discussions is also claiming that DTC advertising doesn’t do so. There’s a disturbing undercurrent of social conditioning here that is played up or played down depending on what is most convenient for prescription drug companies. … The CommonHealth PR logic needs to be kept as far away from the proposed Comparative Effectiveness Institute—and health care in general—as possible.”

At Drug Wonks under the headline “The Cost-Containment Dirty Work Bill,” Dr. Robert Goldberg says, “And what will people do while these experts mull over outdated one size fits all data about ‘what works in health care?’ Suffer or pay out of pocket?” He sees the recommendation against prostate cancer screenings for men over 75 as a “Dry run for comparative effectiveness.” (FYI: Dr. Goldberg’s posts continue to be overwhelmed by spam commentary, so I can’t provide you any links; something must have been fixed, though, because you can now click on Peter Pitts’ posts and actually get the permalinks.)

Speaking of the prostate cancer screening recommendations, Jacob Goldstein at the Wall Street Journal Health Blog takes a look at the reasoning why the recommendation was made. “So a patient is left with this quandary: Screening may increase risks by leading to unnecessary treatment (and side effects) for a tumor that would never have been a problem,” he says. “On the other hand, screening may decrease risks by detecting a tumor that could have turned deadly without treatment.”

Comparative effectiveness already seems to be gaining a foothold at FDA. Ramsey Baghdadi at the InVivo Blog says the rejection of Vanda Pharmaceuticals’ iloperidone indicates that FDA is increasingly using comparative effectiveness in considering new drug approvals, particularly for new antipsychotics.

Matthew Holt at the Healthcare Blog gives us an explanation of how exactly NICE works and why a NICE-type organization probably won’t be able to be successfully established in the United States.

A bold move, to be sure

Lilly’s move to sell Covance its Greenfield R&D laboratory has gotten some positive reception, as Kevin Grogan at PharmaTimes has noted. Mr. Grogan writes, “Analysts reacted well to the deal and Eric Coldwell at Robert W Baird & Co issued a research note saying that ‘our initial take is extremely positive.’ He noted that the transaction ‘accelerates a trend of major pharmas reducing internal capacity and outsourcing CROs, in order to save time and money in drug development, improve overall infrastructure efficiency and remain competitive in a challenging pharmaceutical environment.’”

Mr. Silverman picked up the news here. On a side note, earlier this week, I complained about the evasiveness of the PR agency that seemed to be handling how the press were being alerted about the announcement.

I’d say Dezenhall bungled this one. Lilly’s move really is an indicator of how pharma companies may have to operate in the future to survive, especially as companies cut their early-stage research (Dr. Derek Lowe at In the Pipeline writes about the layoffs at GlaxoSmithKline’s oncology unit and some rumblings at Roche’s Palo Alto site; a quick look around Cafe Pharma seems to indicate it may be the Syntex site closing). Folks like Mr. Silverman, Mr. Goldstein, and maybe even me should have been getting offers of interviews with executives involved in the deal. But no, that’s not the case.

Robert Longman at the InVivo Blog has more about the deal. “It was hardly groundbreaking, as the Covance/Lilly deal was described by one of the PR flaks who’d pre-alerted us to the deal …
But as one piece of the overall strategy Lilly has been fitting together over the last few years, it does indicate to us that those isolated Indianapolites are now the leading Big Pharma thinkers when it comes to financing R&D,” he says.

Information hunt is on

As Mr. Silverman noted last week, the House Energy and Commerce Committee wants FDA to turn over the results of the analysis that looked into the potential links between Vytorin and cancer. Mr. Goldstein writes about the request from Rep. John Dingell here.

Around and about …

CME controversy continues at the Carlat Psychiatry Blog. Dr. Daniel Carlat looks at the reaction BusinessWeek’s article about industry-funded CME provoked from pro-industry-CME bloggers. “We all have our conflicts of interest, and our conflicts inevitably inform our opinions,” he says. “However, to those who base their arguments on attacking my conflicts, please make sure to disclose your own.”

Last week, Dr. Carlat posted the news that the Massachusetts Legislature passed a disclosure bill and a partial gift ban. Thomas Sullivan argues that the ban is “a case against night shift work.” And Mr. Silverman at Pharmalot says pharma trade groups are already protesting the bill.

Both Mr. Silverman and Merrill Goozner at GoozNews look at Forbes‘ article about why you never hear from FDA about approvable/nonapprovable letters. Mr. Silverman says FDA’s move to issue complete response letters instead of approvable or non-approvable letters “may only make it harder to discern just how much more distance must be traveled before a drug can be approved.” Mr. Goozner agrees with Forbes that the law preventing FDA from releasing the letters should be repealed.

Jim Edwards at Jim Edwards’ NRx calls GlaxoSmithKline’s oncology unit trims “a classic example of how not to handle layoffs.” He has more details about the layoffs over at his blog at Bnet.com (and why am I not surprised that the Italian scientists staged a strike). Mr. Edwards takes to task GlaxoSmithKline over its lack of definitive news on the layoffs. “I’ve said it before and I’ll be forced to say it again: Transparency is the key,” Mr. Edwards says. This round of layoffs could have been a blip on the radar had it been announced with some definitive facts, contrite statements, and a feasible explanation of the strategy. … If only those American, British and Italian scientists had known that, they could have spent some time updating their resumes … and GSK would have gotten a lot less bad press over what is, in the grand scheme of things, not the worst layoff mess in the business right now.”

Mr. Edwards also wonders whether Schering-Plough’s productivity measures are actually making the company less productive.

Philip Dawdy notes Seroquel’s popularity as a street drug, so much so that some patients are willing to fake schizophrenia to get it. And, Paxil as a PMS treatment? Are you kidding me? I know that “Mad Men” is a popular show right now, but I didn’t realize we were heading right back into the ’60s when considering women’s issues.

Rich Meyers at World of DTC Marketing examines how e-marketers are still struggling to get their clients interested in the medium. He also looks at how Mac is helping doctors integrate their iPhones into their practices.

Who will be the No. 1 pharma company in 2014? Mr. Silverman writes here and and Mr. Goldstein at the Wall Street Journal Health Blog writes here about a ranking released by Evaluate Pharma that puts Roche at the top.

John Mack at the Pharma Marketing Blog fills us in on the most recent adventures of FDA Intern. This time, Mr. Mack looks at FDA’s “Affect Misattribution Procedure” that the agency is using to evaluate DTC ads, using two political campaign ads, and he wants us to participate in a poll. I am not quite sure what he’s driving at, but my assumption is that you’ll designate one Chinese character as more pleasant than the other based on how you already feel about the ads being played (he’s using anti-Obama and pro-Obama ads as his example). I’d be interested in seeing how the poll turns out.

Another long time, no hear from Dr. Nancy Smerkanich at Octagon Research Solutions’ Regulatory Matters blog. She’s happy that FDA got rid of approvable letters.