Schwitzer health news blog

How will the FDA regulate drug promotion via blog, podcast, social network, etc.?

John Mack tackles the question on his Pharma Marketing blog.

Stumble It!

Terrific WSJ story on FDA device approval

Front page. More than 2,000 words. The kind of story Americans need to understand. We're fortunate to have the WSJ on days like this with stories like this. - "FDA Backs Knee Device After Long Lobby Effort."

Stumble It!

Is "substantially equivalent" good enough for approval of new medical devices?

I think the American public would be shocked if they knew the guts of what was in the GAO report yesterday, "FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process."

The report suggests that FDA review and approval of new medical devices has been lax, allowing companies to get approval through an easier process whereby they only had to show their idea/product was "substantially equivalent" to an existing product on the market. But that loophole was only meant for the smaller toys of the medical arms race. It wasn't meant for metal hip joints, pacemaker electrodes and pedicle screws for spinal surgery - all of which slipped through the easier review process, according to the GAO.

And journalists and the public should take this into account when they hear or report news of FDA approval of some devices. It's NOT terribly big news, in my view, to trumpet FDA approval of something that's only judged substantially equivalent to something already on the market.

NBC, for one, gave a big chunk of precious airtime to FDA approval of a laser hair comb. Whoopee. Our review on HealthNewsReview.org showed that it was only judged to be substantially equivalent to 10 other products already on the market!!!

Breakthrough? Depends on how you spell hype.

Stumble It!

Saga of the heart sock continues

I've been tracking news coverage of a Minnesota company's heart "sock" device for heart failure for four years. Four years ago, I questioned Star Tribune coverage.

Two years ago, questions of evidence started to surface.

Today the Star Tribune reports:

"The high-profile consumer advocacy group Public Citizen expressed "deep concern" this week about whether the company's experimental device has been sufficiently reviewed by federal regulators. ...

Two advisory panels for the FDA have recommended against approval of the Acorn device after reviewing the company's application and holding public hearings. The agency itself has rejected the company's application three times. Acorn has even taken its case to a dispute resolution panel, a highly unusual move in the device world, which also voted against approval of its device.

Normally, a company in this situation would have abandoned the rather-expensive effort, especially a start-up like Acorn, which has no other products on the market.

But Acorn has been encouraged along the way by Dr. Daniel Schultz, a surgeon who is head of the FDA's device division, and the company subsequently reached an agreement with the agency to conduct a second, albeit smaller, clinical trial involving 50 patients. If that study is successful, the device could be approved by the agency without being first reviewed by an advisory committee and without a public hearing, according to Public Citizen.

In a Nov. 12 letter to Schultz, Public Citizen said the design of the new study "is so poor that it is unlikely to provide reliable data that would contradict the negative findings of the data so far submitted to the FDA." The number of patients enrolled in the study is too small, and they will not be followed for a sufficient amount of time, Lurie said."

I never would have picked up on the scent of this story had not the Star Tribune given such favorable coverage to the company and its product four years ago.

Stumble It!

Patients v. Pharma

See Niko Karvounis's blog entry, "The Case of Patients v. Big Pharma." It starts:

On November 3rd the Supreme Court will hear the case of Wyeth v. Levine, which has been called the “business case of the century�—and with good reason. In essence, Monday’s ruling will decide if patients have the right to sue pharmaceutical companies for personal injuries stemming from prescription drugs approved by the Food and Drug Administration (FDA). This is the big one, folks.

Stumble It!

Medical device ads more troublesome than drug ads?

The US Senate Aging Committee was looking at medical device ads yesterday.

The AP reports:

While spending by the device industry is minuscule by comparison (with drug ads), several of the biggest players are adapting similar high-profile tactics.

Johnson & Johnson currently promotes its orthopedic hips with a TV advertisement featuring Duke University basketball coach Mike Krzyzewski. Biomet has promoted its competing products with spokeswoman Mary Lou Retton, an Olympic gymnastics champion.

Unlike ads from pharmaceutical companies, medical device spots are not required to give equal balance to risks and benefits of their products. Because of that, they can "create unrealistic expectations among patients and lead to overutilization of inappropriate and costly, unproven technologies," said Kevin Bozic, a board director of the American Association of Orthopedic Surgeons.

Consumers Union called for device ads to include information about infections and other complications. a CU news release stated:

A recent FDA report on data collected from fiscal year 2006 found a 25 percent increase in adverse events linked to medical devices over the previous fiscal year, including 2,830 deaths, 116,086 injuries, and 96,485 malfunctions. The CDC's National Nosocomial Infections Surveillance (NNIS) System Report shows knee and hip replacement surgery to be a serious source of infection. In some of the NNIS reporting hospitals, the risk of infection may run as high as five percent or more.
Warnings of side effects associated with implantable medical devices in direct consumer ads are generally non-existent or minimal. A review by Consumers Union found no advertisements that advised consumers of the very real possibility of deadly infections or of the need to seek out surgical centers with low infection rates.

The New York Times reported:

"...some experts maintain that the advertising of a medical device can have more of an impact on a patient’s well-being than a drug, because devices often require surgery to implant and may remain inside the body for years.

'The results are irreversible because you are kind of stuck with a device,' said Dr. Kevin J. Bozic, a professor of orthopedics at the University of California, San Francisco."

Stumble It!

Should Pharma PR Pros Write the Government’s Advice to Consumers?

The FDA has launched a new website, “Be Smart About Prescription Drug Advertising: A Guide for Consumers."

But Merrill Goozner and the Integrity In Science Watch project of the Center for Science in the Public Interest distributed a news release with their concerns. Excerpts::

Drug ads can be confusing and often deceptive, so it makes sense that the Food and Drug Administration would develop a web site aimed at helping consumers separate fact from fiction. But to develop such a site the FDA turned to a nonprofit front group erected by Shaw Science Partners, a public relations firm that specializes in launching new drugs such as Viagra, Celebrex, Zoloft, Cymbalta and the now-withdrawn Rezulin.

CSPI today called on the FDA to scuttle the web site, to terminate its relationship with the drug companies’ PR. firm, and to seek out advice from leading physicians, pharmacists, or consumer groups before publishing a new site aimed at educating consumers. The connection between the FDA site and the Big Pharma PR. firm was reported this morning in Integrity in Science Watch, published by the Center for Science in the Public Interest. ...

“It’s not that any of the information presented on this web site is wrong, per se,� said Goozner. “But if the goal were to educate consumers about drug ads, the site is a dismal failure. Nowhere are consumers encouraged to view drug ads with any kind of skepticism. Nowhere are consumers urged how to evaluate messages about side effects. The agency basically invited an industry-funded front group to write the advice. Not surprisingly, they delivered a turkey.�

Stumble It!

Big Pharma & Big Politics

The Wall Street Journal reports:

Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. ...

FDA officials "are too cozy with the companies they regulate," Sen. Chuck Grassley (R., Iowa) said, adding that new leadership must "fix the culture." ...

"There's a total inability of the FDA to carry out" its mission," said Rep. John Dingell (D., Mich.)

Meantime, the folks at the Center for Media & Democracy on their PRWatch.org website caught a couple of things I had missed regarding Big Pharma and Big Politics.

Pushing Prescriptions

Source: Center for Public Integrity, June 24, 2008

"Washington's largest lobby, the pharmaceutical industry, racked up another banner year on Capitol Hill in 2007, backed by a record $168 million lobbying effort," reports M. Asif Ismail. The spending, from companies and trade associations including Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization, jumped 36 percent over the previous year. Much of the increase went to Democrats, after they became the majority party in Congress. "In the current election cycle so far, for the first time on record, the pharmaceutical and health products industry has given slightly more money to Democrats than Republicans," Ismail notes. Just two years earlier, "Democrats received only 31 percent of the contributions from the industry, while the Republicans received 67 percent." The industry's lobbying successes have included "thwarting congressional efforts to restrict media ads for prescription drugs," "blocking the importation of inexpensive drugs from other countries," and "ensuring greater market access for pharmaceutical companies in international free trade agreements."

If You Can't Beat 'em, Hire 'em

Source: Wall Street Journal (sub req'd) July 23, 2008

Daniel Troy served as chief counsel for the U.S. Food and Drug Administration from 2001 to 2004. Starting September 2, 2008, he will be head counsel for the pharmaceutical company GlaxoSmithKline. Before his stint at the FDA, Troy "fought the agency on behalf of the right to use medical-journal articles to suggest off-label uses for drugs and medical devices." He was also an active litigator who worked against consumer interests. "Representing the Washington Legal Foundation, an industry-supported business think tank, Mr. Troy argued for the protection of commercial speech. ... He was also part of the winning team representing Brown & Williamson in a suit against the FDA regarding tobacco advertising." At the FDA, he was known as a loyal friend of the very industries the regulatory agency is charged with monitoring. "Under Mr. Troy, the agency began filing amicus briefs opposing lawsuits against drug and medical-device makers, saying that having met the FDA's approval and labeling standards, manufacturers should be protected from state-based suits for damages." His move to GSK is another example of the revolving door between government and industry. GSK said of Troy, "His wealth of experience in the regulatory legislative area will be of enormous benefit to us, and ultimately to patients."

Stumble It!

Here's why off-label drug marketing is off the charts

The AP reports on a Government Accountability Office analysis of FDA monitoring of off-label drug promotion - which means marketing of drugs for purposes for which they are not approved. Excerpt:

"The situation has raised concerns for Sen. Charles Grassley of Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use.

The review that Grassley requested by the investigative arm of Congress found that the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses.

The FDA "isn't keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it's the FDA's job to enforce that law," Grassley said in a statement. "As a result, drug makers aren't being held accountable for promoting unapproved use of medicine and patient safety is diminished."

Instead, the job is handled by the office that oversees all drug advertising, including television commercials and magazine ads. That office has 44 full-time employees assigned to review ads. Last year, they had to dissect the fine print on some 68,000 advertisements."

Stumble It!

FDA sending far fewer warning letters to pharma

This came out on a Friday afternoon, but should not be lost in the black hole of weekend news.

The Wall Street Journal reports:

The drug industry has been grumbling over how tough on safety the FDA is these days, but by one measure the agency has fallen off significantly a few years ago. The number of warning letters the FDA sends out has been cut in half in recent years. ...

David Kessler, who ran the FDA during the Clinton years, said the decline is something of a flag. “The number of warning letters has always been one of the surrogate measures of FDA’s enforcement performance,� he said. “It’s not the only measure, but any significant drop raises significant questions of what’s going on.�

Stumble It!

Why didn't FDA act on Procrit ads?

The Cancer Letter reports:

Internal FDA documents show that the agency made a series of unsuccessful attempts to stop a direct-to-consumer advertising campaign that claimed that Johnson & Johnson’s erythropoiesis-stimulating agent Procrit (epoetin alfa) improved “fatigue� associated with chemotherapy-induced anemia.

The advertising campaign, which is widely credited with making ESAs into the biggest-selling class of oncology drugs, was allowed to proceed with relatively minor changes after the FDA Office of Chief Counsel became involved in the controversy.

Stumble It!

Getting "informed consent" for drug trials in poor countries

Merrill Goozner reports that the FDA decided that it will no longer require that clinical trials submitted to the agency to get regulatory approval for a new drug adhere to the Helsinki Declaration.

Why should you care? Gooz says this "increases the likelihood that more trials will go abroad and that more of them will not even be registered with the FDA, which makes them all but impossible to monitor."

Huge issue. And, as Gooz points out, one not reported by many news organizations.

Stumble It!

Drug companies' 1,044 broken promises

Bloomberg News reports:

Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators, according to data released today.

The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA.

To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to market. The research is usually voluntary, and lawmakers have repeatedly complained it isn't completed. President George W. Bush signed legislation in September that allows the FDA to require certain post-approval studies.

``Drugs often come on the market with an expectation that studies will be conducted,'' said Peter Lurie, deputy director of the Health Research Group at Washington-based Public Citizen, an advocacy organization, in an interview. ``In fact, many of these studies begin late or do not begin at all.''

Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don't emerge until products are in widespread use.

Some research has been pending for years. Of the 1,044 studies that hadn't begun, drugmakers committed before Oct. 1, 2004, to undertake 444 of them, according to the FDA.

So don't be surprised when you hear the next news about a "blockbuster" drug that is found to have "surprise" side effects months or years after it's been on the market.

Stumble It!

Dingell buries von Eschenbach: "I didn't fall off the cabbage wagon yesterday."

The RPM Report states:

There’s no love lost between Rep. John Dingell and FDA Commissioner Andrew von Eschenbach. That tenuous relationship—and a little congressional theatrics—were on display during the Energy & Commerce hearing into FDA’s overseas drug inspections process....

The Michigan Democrat took issue with FDA commissioner Andrew von Eschenbach’s broad plan to overhaul the agency’s overseas drug inspection structure to avoid another heparin situation during an E&C Oversight and Investigations Subcommittee hearing. Von Eschenbach was trying to explain that it’s not just the number and frequency of inspections by inspectors, but how the inspections are carried out that matter.

Dingell was having none of what he called the commissioner’s “toe dancing.� Dingell, during his allotted time for question-and-answer, asked von Eschenbach to answer “yes� or “no� to a series of questions. The commissioner started off obliging Dingell but then began getting off track with longer, more verbose answers. ...

Dingell: “I didn’t fall off the cabbage wagon yesterday. I’ve been talking to food and drug commissioners for 40 years. And you’re not the first fella I’ve had to skin for not doing his job and coming up here and defending an indefensible situation. I want to maintain my respect for you but I can’t maintain my respect for you if you keep toe dancing around the hard facts that curse you with the inability to do your job because you don’t have resources.�

Stumble It!

Off-label promotion equals 19th Century medicine

Drs. Adriane Fugh-Berman and Douglas Melnick have written to the FDA:

"Loosening restrictions on the distribution of materials on off-label uses is an abdication of the FDA’s responsibility to protect the public. Off-label uses of pharmaceuticals have not been subject to the testing and review required for marketing approval. The scientific review of evidence of effectiveness and safety that drugs undergo prior to an approved, labeled indication for a drug protects patients. With off-label use, this protection does not exist.

While off-label use is sometimes necessary, it should be undertaken with the care and caution due the uncontrolled experiment to which a patient is being subjected. While some off-label uses are supported by randomized controlled trials, 73% of 150 million off-label prescriptions written in 2001 were for conditions that had little to no scientific support for efficacy.

Belief is an unreliable gauge of efficacy. In the 19th century, physicians believed that mercury, arsenic, and bloodletting were effective for common ailments. More recently, physicians believed that oxygen therapy benefited premature babies when instead it caused blindness , and that menopausal hormone therapy benefited women’s health when the opposite was true . In these and many other cases, randomized controlled trials trumped prevailing medical opinion with truth. While “medically-recognized standards of care� may exist outside of a product’s approved product labeling, it is inappropriate for the manufacturers to create or promote these off-label uses without conducting the studies and applying for the new indication with the agency.

Industry has much to gain, and the public health much to lose, by the implementation of this guidance. Restrictions on off-label promotion of drugs should be strengthened, not gutted. The FDA should not jettison its responsibilities to protect consumers."

Stumble It!

Protesting off-label drug promotion

In his blog yesterday, Merrill Goozner wrote how "Patients Protest Promiscuous Promotion of Off-Label Prescribing."
Excerpt:

A coalition of consumer groups later today will send a scathing letter to the Food and Drug Administration protesting a proposal to give manufacturers a blank check to promote the off-label use of drugs and devices. The letter, signed by Consumers Union, the Center for Science in the Public Interest, the Government Accountability Project and a half dozen other patient and consumer groups, charges the lenient guidelines will undermine the FDA's authority to regulate off-label marketing and lower incentives for firms to conduct rigorous clinical trials or seek agency approval for the uses to which the drugs are being put.

The guidelines mark a "180-degree reversal of prior practice (by) eliminating Food and Drug Administration review of articles that manufacturers plan to distribute to physicians. As a weak and dangerous alternative, the draft guidance proposes a de minimus self-regulating standard," the letter asserts.

Stumble It!

How much will we spend for so modest a benefit?

A great letter to the editor appeared in the Wall Street Journal yesterday:

I am still trying to recover from the Food and Drug Administration's recent decision to go against its advisory panel's recommendation and approve Avastin to treat advanced breast cancer ("Genentech Clears Hurdle on Cancer Drug Avastin," Leading the News, Feb. 23).

Although Avastin is ushering in a new wave of "targeted" cancer therapies, which minimize the gut-wrenching side-effects that many of us previously endured with our cancer treatment, the cost to our health-care system is astronomical. What is the true cost of this drug? While the average charge a provider may pay for Avastin may be $7,700 a month, it certainly isn't what a patient is billed. My experience in reviewing hundreds of medical claims involving Avastin shows that the average monthly patient charge when given in an oncologist's office is closer to $18,000 a month, while many hospitals charge more than $35,000 a month. With 38,000 American women eligible for this drug and an average treatment of six months, we suddenly have several billion dollars added to our annual health-care tab.

If the FDA has been given the power to make decisions that have such huge ramifications, it must be accountable for the cost-benefit ratio of these decisions. In this case, a study showed there was no survival benefit yet the cost will be billions of dollars per year. Is there any wonder why our health-care expenditures are expected to double to over $4 trillion within 10 years?

Peter S. Dumich, M.D.
Augusta, Ga.

Stumble It!

We don't know jack

Journalists Jeanne Lenzer and Shannon Brownlee have a column in this week’s BMJ, “Do we really know the truth about antidepressants?� But the question could be applied to any drug on the market.

They explain that not all drug trials have to be registered and access to full data is constrained by trade secrecy laws that permit companies to withhold all information about drugs that do not win approval for a new indication, even when the drug is already on the market for other indications.

Trade secrecy protection?

Where does consumer protection enter in?

Why aren’t these failed trials made public?

It’s a very thoughtful piece by two of this country’s best health journalists.

Stumble It!

Breast cancer advocate: Patients lose, drug company wins

The FDA overruled its expert advisory panel and approved the drug Avastin for breast cancer. On his Pharmalot.com blog, Ed Silverman writes that this could mark a major shift in FDA standards for evaluating cancer drugs. He writes:

"At issue was whether slowing tumor growth - known as progression-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.

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.’ "

The Wall Street Journal reports that "Avastin costs about $7,700 a month, or $84,700 for an average 11-month course for breast cancer. However, with FDA approval, Genentech will enact a $55,000-a-year price cap." And the Journal further quotes Brenner about the debate over rising prices of biotech treatments. She said, "Where we're talking about the cost of health care, biologics are the elephant in the room."

Stumble It!

FDA considers opening the door to more "off-label" promotion

In a move that leaves you wondering about health policy in this country, the Food and Drug Administration is considering loosening regulations on "off-label" promotion of drugs. The Wall Street Journal reports:

The FDA's move already is raising objections from industry critics. Democratic Rep. Henry Waxman of California wrote to the agency urging it to hold off on issuing the guidelines, which he argued would create a "large loophole" in the laws against off-label promotion. "It's a conflict of interest for the company to be promoting sales when they haven't been able to establish that a drug is safe and effective through the rigorous FDA process," Mr. Waxman said.

On his blog, Merrill Goozner writes:

As the nation grapples with how to pay for skyrocketing health care costs and policy wonks grapple with how to get more physicians to follow evidence-based medical practices, the Bush administration's FDA... has proposed opening the floodgates to wider promotion and use of unproven drugs.

There's a name for that kind of policy: Lack-of-Evidence-Based Medicine.

This is a head-scratcher. It raises anew the old questions about whom the FDA is protecting: citizens or industry.

Stumble It!

You can find experts without conflicts of interest

The FDA has been criticized for how many scientists with conflicts of interest that the agency allows to serve on its advisory committees. The FDA says it can't find conflict-free experts. But a study by the Integrity in Science Watch project of the Center for Science in the Public Interest (CSPI) suggests the FDA isn't looking hard enough.

CSPI reports:

"For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not. ... Choosing well-qualified advisers without conflicts of interest instead of conflicted experts will strengthen the nation's food and drug safety system."

CSPI, along with other prominent science and consumer groups, urged the FDA "to adopt the conflict-of-interest guidelines the agency published last March. Those guidelines would ban anyone with greater than $50,000 a year in financial ties to industry from advisory committees and deny a vote to anyone with lesser conflicts."

-------------------

Meantime, read Maggie Mahar's blog for details on the FDA Science Board report, "FDA: Science and Mission At Risk." Some lowlights:

* “The Information Technology situation is problematic at best—and at worst it is dangerous.�
* “The FDA has substantial recruitment and retention issues�.
* “Critical data…including valuable clinical trial data...are sequestered in piles and piles of paper documents in large warehouses."
* “The FDA has an inadequate and ineffective program for scientist performance."
* "The FDA has inadequate funding for professional development to ensure that staff maintain scientific competence."

Stumble It!

Off-label drug promotion guidelines off-target

Many health policy observers are concerned about the impact of drug company promotion of "off-label uses" - unapproved or new uses of drugs that were approved for another primary use.

The FDA is now drafting guidelines on promotion of off-label uses, but the draft concerns Senator Henry Waxman, as Ed Silverman explains on his Pharmalot blog. Excerpt:

Waxman is concerned the agency is opening what he calls an “ill-advised guidance� and a big loophole for drug and device makers. The plan would allow companies to “short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,� he writes in a letter to FDA commish Andy von Eschenbach. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices, and puts the public at risk for ineffective and dangerous uses of drugs.�

Stumble It!

Caution about behind-the-counter drug idea

Statement of Dr. Sidney Wolfe, Director of the Health Research Group at Public Citizen:

"The idea of behind-the-counter-drugs is not new. The Food and Drug Administration (FDA) has previously considered creating a third class of drugs - an intermediate step between prescription medications and over-the-counter drugs - but has not supported the idea, citing the need for more research. That need still exists today.

It's been 12 years since a U.S. General Accounting Office report, commissioned by Congress, raised serious questions about the usefulness of adding another class of drugs. The report looked at how similar systems - in which pharmacists distribute certain drugs without a doctor's prescription -were faring in 10 countries. The possible risks of behind-the-counter sales, due to inadequate counseling by pharmacists, the costs, usefulness and logistics of adding this third layer of distribution were foremost among the concerns.

There's little evidence that these concerns have been addressed. Many questions still remain unanswered. Will pharmacists have the training and the time to explain the drugs and side effects to patients? Who will pay for that training? Will this third class pull more from drugs currently sold over the counter or from those requiring a prescription? And will drug companies push to get their current prescription products into this class to avoid regulation? Will behind-the-counter availability effectively turn the drug store counter into a vending machine, free from doctor's oversight? The FDA needs to put more research behind the plan before it tells Congress it's OK to put more drugs behind the counter."

Stumble It!

Drug and broadcast lobbies win again; no drug ad reform

As Ed Silverman reports on Pharmalot.com "intense lobbying by advertising agencies and broadcasters, as well as drugmakers" stifled tougher restrictions in the FDA reform bill.

Get ready for more (name the ads) couples in bathtubs, butterflies in bedrooms, and the famed green recliner. Drug ads, as one advocate gloated, look like they're here to stay.

Stumble It!

Bush administration blocks FDA reform

See Merrill Goozner's blog for a report on White House efforts "to scuttle a key FDA reform."

Stumble It!

Push for tougher FDA conflict of interest policy

Nine prominent physicians, including two former editors of the New England Journal of Medicine, wrote to Senators Edward M. Kennedy (D-MA) and Christopher J. Dodd (D-CT) urging them to vote to limit the number of industry-connected scientists who may serve on Food and Drug Administration advisory panels. Kennedy and Dodd are among the congressmen trying to resolve differences in the drug safety bills that have gone through both houses of Congress.

The physicians wrote:

“Allowing conflicted members of an advisory committee to vote can have serious public health consequences. For example, in early 2005 a FDA advisory committee reviewed the safety of COX-2 inhibitors and concluded that all three of these drugs, including Vioxx, were safe enough to keep on the market. Ten of 32 scientists on that panel had financial ties to manufacturers of the drugs. Had their votes been eliminated, two of the three drugs in that class would have ben voted down by the panel. (Vioxx was, of course, voluntarily withdrawn from the market by Merck in September 2004 because of safety concerns).

It is possible to find unconflicted experts. The FDA could choose its committee members from among the 123,000 faculty at the 125 medical schools in the United States and public health experts at other federal agencies such as the National Institutes of Health (“NIH�), the Centers for Disease Control, and the Veterans Administration. The NIH’s Office of Medical Applications of Research and the Agency for Healthcare Research and Quality’s U.S. Preventive Services Task Force bar any conflicted scientists from serving on the panels that develop consensus statements on the implications of clinical trial evidence. The Center for Evidence- Based Policy at Oregon Health Sciences University bars any conflicted expert from its analysis of clinical trial evidence to determine what drugs, biologics, and devices provide the best medical outcomes; this evidence is then turned over to states for use in establishing what Medicaid will pay for, among other uses."

Stumble It!

Is Avandia the heart risk sequel to Vioxx?

For a good wrapup of issues surrounding the New England Journal of Medicine article by Steven Nissen of the Cleveland Clinic showing that the heavily marketed diabetes drug Avandia from GlaxoSmithKline increases heart attack risk in the millions of patients who have taken it, go to GoozNews.com.

The Wall Street Journal headlined it "Sequel for Vioxx critic" - referring to Nissen who also raised some of the early red flag warnings about Vioxx.

Stumble It!

Advisers urge curb on EPO use; Ads slammed, too

Merrill Goozner reports that an FDA advisory panel has called for "new warnings that will dramatically scale back the use of anti-anemia drugs if the warnings are heeded by the nation's oncologists. You've seen those television ads. They show beaming older cancer patients playing with their grandkids. Why? Now they have the energy because of J&J's Procrit and Amgen's Aranesp."

One FDA reviewer said: "Improved quality of life, fatigue and other symptoms associated with anemia has not been established in properly conducted, randomized, double-blind, placebo-controlled trials." On top of that, two trials were ended early because of concerns over increased mortality. Another trial showed increased mortality and signs of cancer spreading.

The FDA heard patient stories such as this one Goozner cites: "How is it possible that something that was supposed to help me might have made things worse?" asked Lilla Romeo, a 60-year-old breast cancer patient who's been battling the disease since 2000. The false hope offered by the ads run by the companies was "both insulting and cruel," she said.

He also quotes Richard Pazdur, head of the FDA cancer drugs division: ""They (the FDA) have to give the American people a good explanation for why these ads were allowed to continue."

Stumble It!

Drug whistleblower on Procrit promotions

The Wall Street Journal reports on a whistleblower lawsuit against Johnson & Johnson, with allegations about how the company tried to push sales of the anti-anemia drug Procrit "by offering contracts that fattened doctors' profits and urging its salespeople to push higher-than-approved doses." More:

"Dean McClellan, who worked for 12 years at J&J's Ortho Biotech unit selling Procrit, saved 15,000 pages of company memos, contracts and other work-related documents in a storage unit and shed he built off his garage. He says he was forced to retire in 2004 because the company told him his sales increases weren't high enough. He believes the company wanted him out because of his age, which was 55 at the time. Angry, he agreed to join a whistleblower lawsuit by another former Procrit salesman, Mark Duxbury. A brief filed by J&J says Mr. Duxbury was fired in 1998 for racial and sexual harassment. Through his attorney, Jan Schlichtmann, Mr. Duxbury says he was a star salesman for Ortho whom the company turned on after he told the truth about their business practices at a court-ordered deposition."

An FDA advisory committee meets today to reconsider the risks and benefits of Amgen’s Aranesp and Johnson & Johnson’s Procrit for cancer patients on chemotherapy.

The Wall Street Journal Health Blog reports: "The deliberations and recommendations of the panel could exert a powerful effect on use of the anemia drugs, whose side effects in some patients have raised questions about how broadly and aggressively they should be prescribed. A bunch of briefing documents appeared online today, and they show that the drugs could face a tough go of it."

Stumble It!

Panel pans pain drug

An FDA advisory committee voted 20-1 to reject Merck's request for approval of their hoped-for successor to Vioxx, Arcoxia.

Dr. David Graham said "What you're talking about is a potential public health disaster."

The panel's patient rep, Martha Solonche, said, "The idea should not be we need new drugs. The idea should be we need better drugs."

Stumble It!

New pains for painkillers

Arcoxia, Merck's new painkiller, comes up for review by an FDA advisory committee tomorrow. The Wall Street Journal Health Blog reports that a memo released yesterday "sets up the likely standard for Arcoxia’s review." Memo excerpt:

“…a new product that appears to have an increased overall risk profile for CV disease, particularly beyond that seen with other drugs, would not be appropriate for marketing unless the product fills an unmet medical need for a particular patient population that has no relatively safer approved products available to them, and provides a reasonable risk to benefit balance for that population.�

And the Public Citizen Health Research Group - a watchdog agency - asked the FDA " to order Pfizer to immediately stop its misleading 2 ½ minute television advertisement for Celebrex that began airing on April 2nd."

Public Citizen faults the Celebrex ad for:

* asserting, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are no greater than those of any of the other non-steroidal anti-inflammatory (NSAID) painkillers; and

* claiming that there are overall gastrointestinal benefits with Celebrex over two popular, over-the-counter painkillers, while trying to downplay the risk of serious stomach and intestinal problems such as bleeding and ulcers that applies to Celebrex and all other NSAIDS.

Stumble It!

FDA Okays Conflicts on Committee Considering Merck’s New Pain Pill

The Center for Science in the Public Interest reports:

The Food and Drug Administration last week gave three scientists, including two with financial ties to Merck, permission to serve on an advisory committee and to vote on the fate of the company’s new Cox-2 inhibitor pain pill. The Arthritis Drugs Advisory Committee will consider Arcoxia (etoricoxib) when it meets later this month. Preliminary clinical trial data released by the company last year indicated Arcoxia raises blood pressure in some patients, but does not result in the same heart attack risk as Vioxx, the Cox-2 inhibitor Merck removed from the market in late 2004.

According to agency documents that were released last week, the committee will include Robert Levine, a gastroenterologist at the State University of New York, who owns between $25,000 and $50,000 in Merck stock. The FDA identified four gastroenterologists willing to take the slot, but two had more extensive conflicts than Levine. The FDA also granted a waiver to Kenneth Saag, a rheumatologist at the University of Alabama at Birmingham, who receives somewhere between $10,000 and $50,000 a year from Merck. Saag, the FDA said, is expert in analyzing large databases (Merck has tested the drug in over 35,000 patients) and the agency “was unable to find anyone as qualified.� However, the agency admitted that it only scrutinized its current roster of advisers and employees of the National Institutes of Health to identify candidates. Committee chair Dennis Turk, an anesthesiology professor at the University of Washington, also received a waiver for the $10,000 a year or less he earns from a company that competes with Merck on unrelated issues.

The Wall Street Journal reports:

Merck tested Arcoxia in a massive study, called Medal, that included 34,701 patients enrolled in three trials. The study showed a similar cardiovascular risk for Arcoxia and an older drug, diclofenac. But FDA committee members may question the use of diclofenac as the comparator, because while diclofenac is not categorized as a Cox-2 drug, experts including the American Heart Association view it as closer to the Cox-2s than other painkillers in its class. "What they did is say, our Cox-2 is similar to another Cox-2," says Bruce Psaty, a professor at the University of Washington who wrote about the issue in a recent New England Journal of Medicine commentary. "That's not terribly reassuring."

Steven Nissen, immediate past president of the American College of Cardiology, also pointed out that more patients on certain Arcoxia doses dropped out of the study due to high blood pressure. "I do not believe that [Arcoxia] should be approved," he said.

Wanna bet on the outcome?

Stumble It!

Lots of drug-related conflict of interest news this week

Gardiner Harris of the New York Times is all over issues about drug company influence on doctors and on the FDA this week. Today he writes:

Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees.

Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.

A “significant number� of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many.

Yesterday, Harris' story on "Doctors' Ties to Drug Makers Are Put on Close View" simply blew away the competition - better by far than any other story I saw on the subject in many media across the country - including right here in Minneapolis. He and Janet Robert reported on records in Minnesota, where drug makers are required to disclose payments to doctors.

The Minnesota records are a window on the widespread financial ties between pharmaceutical companies and the doctors who prescribe and recommend their products. Patient advocacy groups and many doctors themselves have long complained that drug companies exert undue influence on doctors, but the extent of such payments has been hard to quantify.

The Minnesota records begin in 1997. From then through 2005, drug makers paid more than 5,500 doctors, nurses and other health care workers in the state at least $57 million. Another $40 million went to clinics, research centers and other organizations. More than 20 percent of the state’s licensed physicians received money. The median payment per consultant was $1,000; more than 100 people received more than $100,000.

The reporting on this latter story was complete and comprehensive, with many examples of Minnesota physicians receiving surprising amounts of money from drug companies; ten doctors and one dentist received more than $500,000. You should read the entire story. But be ready to take an anti-anxiety pill when you're done.

Stumble It!

Erythropoietin bad news hidden late on Friday?

Merrill Goozner suggests that the FDA announcement late last Friday afternoon, issuing an official warning against giving cancer patients erythropoietin drugs (Epogen, Procrit, Aranesp) for anemia, was timed to minimize bad news or embarrassment. Goozner writes:

"What struck me most about yesterday's announcement was its timing. It has long been a hallmark of White House public relations staff that the best time to release bad news was late on Friday afternoons. That way, the least number of people will hear about it through traditional news media sources. It's too late to make the Friday evening newscasts; and the print stories usually wind up inside the Saturday papers, which are the least read of the week. (The New York Times story, at least, got mentioned on the front page.)

This late Friday afternoon release shows as much as anything how the culture of the agency has been transformed in recent years from industry watchdog to industry lapdog."

Stumble It!

Taking Back the FDA - at a cost of a day in Iraq

Former New England Journal of Medicine editor Marcia Angell had an editorial in the Boston Globe last week that should not be missed. Excerpts:

"It's time to take the Food and Drug Administration back from the drug companies. … (I)n 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay "user fees" to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process.

At $300 million to $400 million a year, the equivalent of about a day in Iraq, Congress can easily afford to buy this vital agency back for the public, and it should."

Stumble It!

In search of conflict-free experts

The Integrity in Science Project of the Center for Science in the Public Interest reports:

"The Food and Drug Administration's latest report on the make-up of its advisory panels reveals that little has changed in the 15 months since Congress required the agency to document its efforts to find scientists without ties to industry. In a report sent to Capitol Hill on Jan. 31, FDA Commissioner Andrew von Eschenbach reported that 24 percent of advisers to the agency’s seven centers and offices received conflict-of-interest waivers between November 2005 and January 2007. The Center for Drug Evaluation and Research (CDER) had the worst performance, with 146 of 417 advisers, or 35 percent, requiring waivers because they owned stock in, consulted for, or served on the speakers' bureaus of firms with products up for approval or their competitors.

The agency's ability to identify advisers without conflicts of interest has not budged since Congress acted. ...
When questioned about the agency's failure to reduce its reliance on outside advisers with ties to industry, acting deputy commissioner Randall Lutter said that 'it is very difficult to get the quality of the expertise we want without going to people who have some sort of relationship with industry related to product development.' But as a Lancet editorial noted in 2005 shortly before Congress passed its law, 'it is hard to believe that in a country with 125 medical schools – not to mention the pool of international experts – the FDA cannot find experts who do not have financial ties with companies whose products are under review.' A New York Times editorial has pointed out that 'unless the FDA makes a more aggressive effort to find unbiased experts or medical researchers start severing their ties with industry, a whiff of bias may taint the verdicts of many advisory panels.' "

Stumble It!

Think of Baycol when you hear new drug hype

Whenever I think about premature enthusiasm for new drugs, when I hear doctors talking about putting statins in the water supply, when I hear news reports that a drug is safe -- I think of Baycol. The statin drug was approved about ten years ago, but pulled from the market about five years ago after being linked to 31 deaths.

The Houston Business Journal now reports:

"Bayer Corp. will pay $8 million to 30 states, including $200,000 to Texas, as part of a settlement requiring the company to fully disclose when drugs pose risks for patients with specific health conditions.

The terms of the judgment require that Bayer register its clinical studies and, upon the completion of each study, post the results on the Internet. The marketing, sale and promotion of Bayer's pharmaceutical and biological products must comply with the law and cannot include false or misleading claims."

Stumble It!

Waiving conflict of interest on FDA panels

The Center for Science in the Public Interest (CSPI) reports on multiple waivers of conflicts of interest on three recent FDA advisory panels. Three experts with financial conflicts were allowed on this week's advisory panel on adult suicide risk from antidepressants. According to CSPI, one received between $10,000 and $50,000 per year from one of the companies affected by the panel hearing.

Last week, seven waivers were granted to members of a panel discussing safety concerns about Sanofi-Aventis' antibiotic Ketek.

And the FDA gave financial conflict-of-interest waivers to six physicians who sat on the advisory panel that evaluated the safety of drug-eluting stents made by Johnson & Johnson and Boston Scientific.

CSPI does a tremendous public service by disclosing what's going on at the FDA. The public - and many journalists - don't know the extent to which conflicts of interest may impact the integrity of science and of health care recommendations. We need to have a deep and ongoing public discussion about what these conflicts mean, how to judge them, and how to ensure unbiased review of new drugs and devices given the prevalence of conflicts of interest among America's physician-researchers.

Stumble It!

Fox guarding even more hen houses at FDA

Several news organizations - the Wall Street Journal and American Public Media's Marketplace - have reported that the Food and Drug Administration has reached an agreement with the pharmaceutical industry that would require companies, for the first time, to pay fees to the FDA for the work of reviewing their TV drug ads, in exchange for speedier reviews. The Wall Street Journal story included this line: “The FDA is unusual among federal agencies because it negotiates with the companies it regulates, which are represented by their major trade organizations, over the amount and use of fees the industry pays to the agency.“

“Unusual� is mild. Controversial is more direct and appropriate. The current system of industry user fees has been criticized because of the potential pressure and conflict of interest it places on reviewers. In the Marketplace piece, Professor Steven Schondelmeyer of the University of Minnesota says, "It does create sort of a provider-client relationship where the agency begins to view that they're working for the industry that they're regulating, moreso than they're working for the public as a whole."

Don’t expect this move, if it happens, to put much more than a little speed-bump in the path of the runaway and troublesome TV drug ad business.

Advertising Age reports that such advertising budgets have boomed in the past ten years, from $12 million to $4.1 billion.

Stumble It!

FDA Warns Against Guidelines Backed by National Kidney Foundation

From the Integrity in Science project at the Center for Science in the Public Interest:

"The New England Journal of Medicine last week published a Johnson & Johnson-funded clinical trial showing that patients with failing kidneys who were given high doses of Amgen's anti-anemia drug Epogen suffered 34 percent more heart attacks and strokes than patients given lower doses nearer to the FDA-approved standard. A comment that appeared in the Lancet online pointed out that the higher dose achieved in the study was within guidelines recently issued by the National Kidney Foundation, which received 57 percent of its $19.7 million budget in 2005 from corporate and organizational partners, including $4.1 million from Amgen and $3.6 million from J&J. Amgen and J&J compete with variants of Epogen sold as Aranesp and Procrit, respectively, in the oncology market. The Food and Drug Administration late last week warned physicians not to exceed agency-approved prescribing levels for Epogen, Aranesp and Procrit. "

Stumble It!

The Best Advice is Free – From Conflicts of Interest

The Center for Science in the Public Interest wrote the headline above for a statement CSPI issued last week.

The statement was written by CSPI Integrity in Science Director Merrill Goozner concerning U.S. Senate Bill 3807. He wrote:

"There are three crucial FDA advisory committee meetings coming up in December. One will discuss drug-eluting stents on December 7-8; one will discuss antidepressant use and adult suicidality on December 13; and one will discuss the antibiotic Ketek on December 14-15.

The scientists who advise the FDA should be free of all financial ties to firms whose products are under review. The public’s faith in the integrity of the process will be undermined by any reform legislation that allows physicians and scientists with conflicts of interest to continue serving on these committees."

Stumble It!

Most defective medical device ever OK'd by FDA?

Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, criticizes the FDA's approval of silicone gel breast implants, calling them "the most defective medical device ever approved by the FDA."

Wolfe, in a statement on the Public Citizen website, writes: "The approval makes a mockery of the legal standard that requires 'reasonable assurance of safety.'

This approval of such a defective medical device raises again the larger issue of the poor leadership and dangerously poor performance of the FDA’s Center for Devices and Radiological Health (CDRH). Recent examples of this include the large number of defibrillator and pacemaker recalls, primarily the fault of manufacturers such as Guidant but abetted by the lack of FDA promptness, and the approval of the vagus nerve stimulator for depression despite the opposition of dozens of FDA staffers because it lacked evidence of effectiveness."

Stumble It!

Does FDA approval mean safety?

The National Research Center for Women & Families released a report that suggests a lot of FDA rubber-stamping of approval of new medical devices and drugs.

A news release on the group's website quotes Center president Dr. Diana Zuckerman:

"From our analyses of the FDA advisory committee voting patterns and committee discussions, our study shows advisory committee members usually recommending approval, even if they have strong concerns about the products' safety and effectiveness. And, on those rare occasions that the advisory committee opposes approval, the FDA frequently approves the product anyway. That is especially likely for medical devices." ... "Our study indicates that even one committee member with a financial conflict of interest could easily influence the votes of the entire committee, and thus the FDA decision to approve the product."

Stumble It!

Politicizing the FDA

Was the FDA's surprise announcement that it would reconsider an effort to make the emergency contraceptive Plan B drug available without a prescription a political move on the eve of Senate hearings on the confirmation of Acting Food and Drug Administration Commissioner Andrew C. von Eschenbach?

The Washington Post reports that much of the hearing focused on the politicization of the agency.

The Post reported that Sen. Barbara Mikulski (D-Md.) said, "There is a crisis of confidence at FDA."

"More than 100 whistle-blower cases are pending at the agency, Mikulski noted -- an outgrowth, she said, of rock-bottom morale, much of it rooted in the perception that the Bush administration is imposing ideology over evidence.

Several senators cited a recent survey by the Union of Concerned Scientists in which more than 40 percent of nearly 1,000 FDA employees said they knew of cases in which political appointees had interfered with agency decisions."

Stumble It!

FDA scientists asked to distort data

A survey by the Union of Concerned Scientists shows that:

Large numbers of agency scientists reported interference with their scientific work.

* Almost one in five (18 percent) responded, "I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document."

* More than three in five (61 percent) knew of cases in which "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."

* Three in five (60 percent) also knew of cases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions." Fifty percent also felt that non-governmental interests (such as advocacy groups) had induced or attempted to induce such changes.

* Only half (51 percent) feel the "FDA is acting effectively to protect public health."

* One-fifth (20 percent) say they "have been asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials." In addition, more than a quarter (26 percent) feel that FDA decision makers implicitly expect them to "provide incomplete, inaccurate, or misleading information."

* Two in five (40 percent) said they could not publicly express "concerns about public health without fear of retaliation." More than a third (36 percent) did not feel they could do so even inside the confines of the agency.

Nearly 1,000 out of 6,000 FDA scientists responded to the mail survey.

Stumble It!

Prescription for harm: decline in FDA enforcement

Congressman Henry Waxman has published a new report on the FDA - the result of a 15-month investigation. It finds that there has been a "precipitous drop in FDA enforcement actions over the last five years." The main findings:

* FDA enforcement actions have declined under the Bush Administration. The number of warning letters issued by the agency for violations of federal requirements has fallen by over 50%, from 1,154 in 2000 to 535 in 2005, a 15-year low. During the same period, the number of seizures of mislabeled, defective, and dangerous products has declined by 44%.
* FDA headquarters officials have routinely rejected the enforcement recommendations of career field staff. Internal agency documents show that in at least 138 cases over the last five years involving drugs and biological products, FDA failed to take enforcement actions despite receiving recommendations from agency field inspectors describing violations of FDA requirements.
* FDA’s recordkeeping and case tracking practices are inadequate.

Harvard's Dr. Jerry Avorn, in a letter accompanying the report, writes, "one is left with the image of an organization unable or unwilling to do its job effectively."

Stumble It!

Hypertension drug panel stacked with industry consultants

The Center for Science in the Public Interest (CSPI) says the Food and Drug Administration’s (FDA) advisory committee on cardiovascular and renal drugs will be chaired by and dominated by industry-connected scientists when it meets today to evaluate draft labeling guidance for antihypertensive drugs. CSPI has urged the FDA to postpone the meeting to take the time to identify panelists who are free of conflicts of interest, and who could bring balance to the panel.

A balanced panel would at least have some members with expertise on how hypertension can be treated with diet and lifestyle changes, according to CSPI.

“American hospitals and medical school faculties are filled with experts on preventing and treating high blood pressure, and it is simply not the case that all of them have financial relationships with drug makers,� said Merrill Goozner, director of the Integrity in Science Project at CSPI. “If the FDA can’t find any to serve on this particular panel, we stand ready to help them identify some.�

CSPI also told the agency that its draft labeling guidance ignores the government’s own advice on the importance of lifestyle changes on lowering blood pressure, misrepresents the findings of the major government-funded science on hypertension, and would permit drug companies to make claims on drug labels that have not been reviewed by FDA. CSPI says that the labeling guidance would open the door for labeling abuse by letting drug companies tout the advantage of one drug over another without much evidence, and would squander and opportunity to educate Americans about the importance of diet and lifestyle in treating hypertension.

“The FDA acts as if it is much more concerned with pampering the pharmaceutical industry than it is preventing disease through better diets,� said CSPI executive director Michael F. Jacobson. “The best science on blood pressure shows that adoption of healthy lifestyles, including losing weight and reducing sodium, is indispensable to reducing blood pressure. Yet FDA does very little to help Americans make those changes.�

Stumble It!

High times in the high blood pressure drug market

Journalist Merrill Goozner, on his blog, calls “attention to some of the complexities that underscore why the FDA’s draft 'Guidance for Industry for Labeling for Outcome Claims for Drugs to Treat Hypertension,' which will be discussed (this) week by the Cardiovascular and Renal Drugs Advisory Committee, is such a curious document. It isn’t so much that it is wrong. It’s what it leaves out and, more importantly, what it puts in that makes one wonder if the agency has sold its soul to the drug industry. …

But the savvy marketing arms of the major drug companies know what’s at stake. Combine a failure to distinguish between drugs with the right to put the misleading claims of seeding trials on labels and what you’ve given them is a blank check to suggest their pricey patented drugs are superior to generic diuretics, even though the government guidelines say just the opposite. The net effect of this Guidance could be a huge setback for public health and the public purse.�

Stumble It!

Going in different directions over Xenical obesity drug

At the same time that the FDA appears headed toward approving the obesity drug Xenical (orlistat) as an over-the-counter drug, the group Public Citizen has petitioned for a ban of even the prescription version of the drug.

Public Citizen today claims the drug has been known to cause a significant increase in a precursor to colon cancer. Last week, the FDA sent an “approvable� letter concerning the over-the-counter (OTC) version of orlistat to GlaxoSmithKline, which has applied to market this version. If the drug company meets certain conditions set by the FDA, the drug would probably be approved for OTC sales

“The failure to ban the prescription version of this drug or, worse, to make it much more widely available by allowing OTC sales, is a decision that is likely to increase cancer incidence,� said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.

“The FDA should not allow a drug … to remain on the market for the long-term treatment of a non-lethal condition when it combines so little efficacy coupled with a still unresolved potential to cause breast and colon cancer,� says the 12-page petition. “[The] FDA is now considering increasing the number of people exposed to the drug by allowing OTC use. There is no scientific justification for this decision.�

Stumble It!

Does the world need another ADHD drug?

Merrill Goozner asks this question on his blog. An excerpt: “With nearly a half million kids on six different mind-bending drugs, you’d think the psychiatric profession already had enough options for attention deficit hyperactivity disorder. But that’s not the way our drug approval system works. It’s a free market out there, open to all comers. So this Thursday the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee will consider another drug for ADHD – Cephalon’s Sparlon, which is generically known as modafinil.

Late night truckers and shift workers are already familiar with this drug. In their sleep-disordered world, it is known as Provigil. It’s not an amphetamine. It’s mechanism of action, to use the mystifying argot of the drug scientists, is “poorly understood.� In layman’s language, that means they have no idea how or why it works.�

Read the rest of Goozner’s article, which discusses suicide risks, bribes, patent expiration and generic drug competition.

Goozner concludes: “I’m sure we’ll hear from plenty of testimony on Thursday from parents and physicians who swear by this new drug. But the jaded business reporter in me wonders if the kids are just pawns in the company’s patent game.�

Stumble It!

Criticism of possible new FDA chief

Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, says that Dr. Andrew von Eschenbach is not qualified to lead the FDA. Here is Wolfe's statement:

"If confirmed by the U.S. Senate to be the next commissioner of the Food and Drug Administration (FDA), Dr. Andrew von Eschenbach will become yet another Bush appointee whose main reason for being selected is that he is a family friend, someone who has been warmly embraced by the regulated industries – especially the pharmaceutical industry – and someone who has been and will continue to be loyal to the White House agenda.

He is a very poor choice to head this critical agency, and his nomination must be defeated. Otherwise, the FDA will be further weakened and the public health further damaged by someone who is so unqualified."

Stumble It!

Conflict of interest on FDA panel

The Center for Science in the Public Interest reports that "five of the eleven scientists so far selected to judge the safety of the new multiple sclerosis drug Tysabri have financial ties to either the drug's sponsors, Biogen and Elan Pharmaceuticals, or their competitors."

An advisory committee of the FDA meets today to reconsider Tysabri, which was pulled from the market last year after a handful of patients developed a rare brain disorder. Two permanent committee members disclosed they earned between $10,000 and $50,000 from either Biogen and Elan by serving on their speakers bureaus or consulting. Three other committee members consulted for or sat on the speaker bureaus of direct competitors. The FDA claims it cannot find experts without conflicts of interest to serve on advisory panels, whose advice it usually follows.

Stumble It!

Yellow light on the fast track

A physician writes about concerns over the fast track approval of new drugs in this week’s BMJ.

Three months after the Food and Drug Administration gave the drug natalizumab accelerated approval for treating relapsing multiple sclerosis, its makers withdrew it after three patients developed life-threatening conditions. Two of them died. The author lists the things that went wrong on the fast track: cumulative safety data weren't available, the trials' end points were dubious, the drug’s mechanism of action was always risky, and the animal model was not suitable.

The drug was licensed by the FDA in 2004 on the basis of short term results from two unpublished trials. The FDA granted approval before final trial and cumulative safety data were available. Natalizumab was predicted to be the leading drug for multiple sclerosis, with estimated annual sales in excess of 2 billion dollars.

The author says this case highlights the potential risks for patients in trials of new drugs where knowledge of long term efficacy, outcome measures, and safety is lacking.

Stumble It!

Medical device makers spin semantics

Bloomberg News reports that the medical device industry is fighting the FDA over the use of the word “recall.� Companies such as Medtronic, Boston Scientific and Guidant have had to deal with the FDA a lot lately over reports of problems with devices such as implantable defibrillators. The FDA calls it a recall when a company has to repair or replace such defective products.

But the industry says “recall� is misleading because faulty device implants don’t have to removed like faulty car parts. So industry wants to replace “recall� with “field corrective actions.�

An industry spokesperson said “We want to communicate clearly with our users and our patients on how to manage our products, and the word ‘recall’ gets in the way.�

Hmmmm. And the words “field corrective actions� help with clear communication?

Stumble It!

10% of 10-year old boys on ADHD drugs!

The Washington Post reports on an FDA advisory panel recommendation to add warnings on attention-deficit hyperactivity disorder (ADHD) drugs because of reports they may have caused sudden deaths or other serious problems.

The Post quotes Dr. Curt Furberg of Wake Forest University Medical School: "On the surface, it is hard to believe. What is also interesting is this condition is not really recognized in other countries -- you wonder what we are treating. I am sure there are patients who need these drugs, but it is not 10 percent of all 10-year-old boys."

Stumble It!

Problems tracking medical device safety

Spurred on largely by recent problems with implantable cardioverter debrillators (ICDs) and pacemakers, the FDA held a rare "media briefing" to discuss the problems the agency faces in tracking the safety of medical devices after they've been approved for use.

The Star Tribune reports the FDA acknowledged it is "challenged by the size and growth of the device industry, the complexity of devices, increased home use of devices and the tension between safety and cutting-edge technology that could improve people's lives."

You could cut and paste those words into a description of the challenges faced in drug monitoring.

The newspaper reports that last week the FDA sent "an unusually harsh and broad warning letter" to the Boston Scientific corporation. "The FDA cited serious quality-control problems -- and inadequate responses to earlier warnings -- at numerous factories operated by Boston Scientific, whose products include the best-selling Taxus stent."

Stumble It!

Why didn't FDA approve Plan B for OTC?

The Washington Post reports that former FDA chief Lester Crawford did not cooperate with an inquiry by the Government Accountability Office into the agency's controversial decision to reject over-the-counter (OTC) sales of the emergency contraceptive Plan B.

Senator Hillary Rodham Clinton released a statement that said, "The draft GAO report appears to confirm what we have suspected for some time: Science was compromised in the FDA's decision-making process on Plan B."

Senator Patty Murray said, "We need an FDA commissioner who is willing to go before the public and explain how agency decisions are made. Refusing to explain his role in this decision is not acceptable."

Of course, Crawford resigned from the FDA job last month. And the FDA assistant commissioner for women's health resigned in late August in protest of the Plan B decision.

Stumble It!

von Eschenbach takes off one hat; future of FDA in question

Dr. Andrew von Eschenbach announced late Friday that he will temporarily give up the head job at the National Cancer Institute in order to lead the Food and Drug Administration.

Merrill Goozner has written about how von Escenbach, at the NCI, "was a forceful advocate for more rapid approvals of new drugs based on inconclusive markers of their efficacy."

Now he'll head the FDA.

Meantime, TIME magazine, in an article entitled "How Many More Mike Browns Are Out There?" reflects on how "many within the department, as well as in the broader scientific community, were startled when, in July, Scott Gottlieb was named FDA deputy commissioner for medical and scientific affairs." TIME reports that Gottlieb had been an editor of a Wall Street newsletter, writing many articles that "criticized the FDA for being too slow to approve new drugs and too quick to issue warning letters when it suspects ones already on the market might be unsafe." Former FDA chief Donald Kennedy, now editor of the journal Science, told TIME, "The appointment comes out of nowhere. I've never seen anything like that."

Journalist Goozner writes, "It this is a harbinger of things to come, the FDA may soon rival FEMA in its ability to serve the needs of the American public."

Stumble It!

Von Eschenbach's two hats

How can someone head the National Cancer Institute and the Food and Drug Administration -- even temporarily? Merrill Goozner has some thoughts about how and why the NCI director was named to replace the departing FDA director.

Troubling times at the top in federal health policy making.

Stumble It!

Protecting deadly drug trade secrets?

Freelance journalist Jeanne Lenzer's piece in Slate, "Drug Secrets: What the FDA Isn't Telling," is important.

An excerpt: "The use of trade-secret laws to conceal deaths and serious side effects linked to drugs has the obvious flaw of putting profits before public health. It also subverts the covenant between researchers and study volunteers. Subjects... are told that even if they do not personally benefit from a new drug, the scientific knowledge gained from the study in which they've participated will benefit others. The volunteers should be told instead that scientists will learn about their experience only if it's good news for the drug they're helping to test."

Read the rest.

Stumble It!

Why did the FDA chief quit?

Politicians have learned to release bad news on Friday afternoons so that the news may get lost over the weekend. Merrill Goozner of the Center for Science in the Public Interest points out this timing, and raises other thoughtful questions about yesterday's resignation by FDA commissioner Lester Crawford.

Stumble It!

More potential conflict of interest in FDA drug review

The Center for Science in the Public Interest reports that the Food and Drug Administration (FDA) is again allowing scientists with direct financial ties to a drug manufacturer to serve on an advisory committee charged with evaluating that company's product.

CSPI says that a committee reviewing the safety and efficacy of Pfizer's proposed insulin inhaler has at least three members with direct ties to Pfizer, the product's manufacturer, or its technological partner, Nektar Therapeutics. One other member-the acting chairman-holds stock in Pfizer.

"The public's faith in the integrity of the process is undermined when one-third of an advisory committee's membership has significant financial ties to the company seeking the product's approval," said Merrill Goozner, director of the Integrity in Science project at CSPI. "It is ludicrous that the FDA could not find highly qualified experts in these fields who did not have ties to the manufacturer."

Stumble It!

Docs criticize sleeping pill ads

What the FDA won't do, some physicians are doing. That is, to talk openly about the claims made by highly-advertised new sleeping pill Lunesta.

The Boston Globe reports on several physicians' criticisms of Lunesta ads. One says the ads don't mention how long the pills can safely be taken and he adds that more long-term studies of sleeping pill safety are needed. Another says "Patients who took this drug did not become normal sleepers." Another says behavioral therapy is preferable to pills for treating insomnia long-term.

The Globe says that a spokeswoman for the FDA said it would not discuss reviews of a particular company's advertising, such as why the manufacturer can claim Lunesta is ''approved for long-term use."

Stumble It!

What do we know (not know) about weight loss drug Meridia?

Dr. Sidney Wolfe, Director of Public Citizen’s Health Research Group, says that FDA denial of his group's petition to ban the weight loss drug Meridia is misguided.

In a statement on the Internet, Wolfe says: "For a drug such as Meridia to be approved or for it to stay on the market, there must be evidence that its benefits outweigh its risks. Evidence prior to its approval and more than 50 cardiovascular deaths, many in young people, since its approval confirm that its benefits do not outweigh its risks and that it should be removed from the market despite efforts by the FDA/Abbott duo to keep the drug alive."

The statement concludes: "Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug. How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to – and makes the agency less vigilant over – the companies that give it almost $200 million a year in funding?"

Stumble It!