Category Archives: FDA oversight

The FDA: What Happens When You Starve the Beast

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In October, I talked to a source inside the FDA who suggested that the agency was having a hard time keeping up with work-flow.  I quoted him on this blog as explaining that since the FDA has committed to reviewing applications for approval of a new drug within 10 months, drug-makers have been submitting “shabbier” applications that contain less evidence about risks and benefits.

“For the drug-maker it’s a gamble. The company is betting that, because we want to make the 10-month deadline, we won’t send the application back,” said the source. And often, he acknowledged, the drug-maker is right. “If you find a problem or there is something missing and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process.”

In the past, he added, a company submitting an application knew that if the application wasn’t up to snuff, the FDA would send it back. But those standards have fallen: “Now we send it back [only] if it’s really crappy.”

Yesterday the FDA Science Board dropped a bombshell in the form of a report which suggests that standards at the FDA haven’t just fallen—they’ve fallen off a cliff. The title of the report says it all: FDA: Science and Mission At Risk.
The problem, according to the report: a lack of funding. The Coalition for a Stronger FDA,  co-chaired by the last three secretaries of Health and Human Services (the department that oversees the FDA), says the FDA needs a 15 percent boost in funding per year for the next five years. 

Here are just a few highlights from the report:

  • “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."

William Hubbard, a former FDA associate commissioner who supports the Coalition for a Stronger FDA, told ABC News that the report stands out because of the "intensity of the feelings" expressed by the subcommittee.

"These people were horrified by what they found," he added.

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How the Media Covers Health Care

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Sometimes health care reporters remind me of the financial journalists who helped hype the bull market of the 1980s and 1990s. I began my career as a journalist at Money magazine, and I remember sitting in an editorial meeting where we talked about an upcoming cover story: “The Ten Best Mutual Funds NOW.”  One intrepid reporter asked: “What if there aren’t ten great mutual funds that you really should invest in right now?”

“Let the fact-checker worry about that,” someone else quipped, referring to the person who would be double-checking the details of the story just before it went to press. Almost everyone sitting around the table laughed.

And Money was generally a pretty responsible magazine that tried to warn investors against the risks of the market. Still, “good news” cover stories sold magazines—just as “breakthrough” medical stories on the local evening news keep viewers from changing the channel.

Gary Schwitzer, an associate professor in the School of Journalism and Mass Communication at the University of Minnesota, recently published a provocative piece about how the media covers health care in the American Editor. Schwitzer begins his piece by asking his reader to “Imagine a reporter filing a story from the Detroit Auto Show. She writes about one car maker’s hot new model as if it is the best thing since the ’57 Corvette. But in the excitement over the chrome and style, she doesn’t mention the cost of the new model, doesn’t compare it with other manufacturers’ offerings in the same class, and doesn’t mention anything about performance (fuel efficiency, handling, braking, safety issues, etc.)

“An editor would certainly raise questions about this kind of puffery.

“But over on the health care beat,” Schwitzer observes, “the majority of stories on new products, procedures, treatments and tests are published without including comparable information. Claims that would never be accepted unchallenged from a politician are accepted unquestioningly from physicians and researchers and company spokespersons.”

Schwitzer, who publishes HealthNewsReview.org, a website that grades health care news stories for accuracy, balance, and completeness, has evidence to back up his claim.  Below I’ve re-posted some of his data on some 400 stories from almost 60 major news organizations (available at his website) to demonstrate how many health care stories “provide a kid-in-the-candy-store portrayal of the health care system that leaves readers with the impression that most products or procedures in health care are amazing, harmless and without a price tag”:

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ADHD and the Medication Feeding Frenzy in America

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CORRECTION: In the post below, I make mention that there has been no U.S. media coverage on the MTA report. But after some further digging, I found coverage from Investor’s Business Daily, along with popular sources the New York Post, and Fox News and technical/niche publications like Planet Chiropractic. So there is some American coverage.

But if you click around you can see that the American stories are much more brief than their international counterparts. Each of the stories in the mainstream outlets is more of a newswire dispatch than an actual article, where as the international stories are comprehensive. And while pretty much all of the news sources of record in the U.K. covered the story, the major U.S. outlets–like the WSJ, NYT, Time, Newsweek, etc–seem to have had nothing.

Given that the U.S. is 90 percent of the ADHD drug market, you’d think that MTA’s findings would make nation-wide headlines. But instead coverage is scattered and superficial. Stories are relegated to quasi-interest group literature (investors who may lose money on the drugs, chiropractors who have a professional interest in questioning medication), or to the News Corporation (which owns both the Post and Fox news)–a multinational company with a strong Australian and British component. There’s still no convincing evidence that the American media is, on the whole, ready to meaningfully cover MTA’s findings.

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Earlier this week the British press broke some startling news: the Multimodal Treatment Study of Children with ADHD (MTA), has issued a report that claims there are no long-term benefits of ADHD medication for hyperactive children. Report co-author Professor William Pelham of the University of Buffalo, is quoted in the British press as concluding that ADHD medication is, in the long-term, all risk and no reward.

“The children [on ADHD medication] had a substantial decrease in their rate of growth so they weren’t growing as much as other kids both in terms of their height and in terms of their weight,” he says. “And…there were no beneficial effects – none.”

This is an about face from MTA’s benchmark report in 1999 that asserted with certainty that ADHD drugs were the best way to address ADHD in children. The 1999 study claimed that “combination treatments” (i.e. drugs and behavioral training) along with “medication-management alone” (i.e. drugs) are “both significantly superior” to other ADHD treatments that don’t include medication.

But, according to Pelham, “we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case.” So, according to Pelham, here’s the bottom line: “in the short run [medication] will help the child behave better, in the long run it won’t.”

To some, Pelham’s report might be unwelcome news. Thanks in part to the medical credibility that MTA and other studies have conferred on ADHD medications, global sales of ADHD drugs are predicted to be $4.3 billion by 2012. This ADHD boom is a recent phenomenon, largely a product of the 1990s. According to the US National Ambulatory Medical Care Survey, the number of children who received a diagnosis of ADHD increased 250 percent from 1990 to 1998. A study from 1996 showed that from 1990-1995 child use of ADHD medication increased by a factor of 2.5 and drug production increased six-fold. The production of Ritalin (the most common ADHD medication) increased by 700 percent from 1990-1999.

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Health Beat Hosts Health Wonk Review

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Today, Health Beat is hosting Health Wonk Review, a biweekly compendium of the best of the health policy blogs. More than two dozen health policy, infrastructure, insurance, technology, and managed care bloggers participate by contributing their best recent blog postings to a roving digest, with each issue hosted at a different participant’s blog.

Thanks to all of you for your submissions. I couldn’t do justice to all of them, but here’s a sampling of some of the best posts about health care on the blogosphere:

At Health Care Policy and Marketplace Review Robert Laszewski takes on Mitt Romney’s assertion that there are “pots of money” in the states –enough to allow states to follow Massachusetts’ initiative and fund health care reform without raising taxes. Laszewski demolishes the argument, pointing out that even Massachusetts doesn’t have enough money to follow Massachusetts’s initiative. That’s why the state has had to exempt some citizens from the mandate that everyone buy insurance.

On Health Access California, Anthony Wright offers the clearest explanation I’ve seen of Governor Schwarzenegger’s plan for reforming care in California, and its merits and limitations when compared to both HRC’s proposal and the Romney plan in Massachusetts.

On Physician Executive, Zagreus Ammon’s ambitious post “Defining Universal Health Care” begins by addressing the theory that each of us is responsible  for our own health—i.e. “that people do well because they make good choices and people do poorly because of poor choices.”

Here Ammon is responding to Peter Huber of Manhattan Institute fame and his editorial in IBD (Investors’ Business Daily) arguing that universal healthcare is an idle dream because eventually, the “pocket-book healthy” (read: wealthy) will get tired of paying for the “health-careless people” who don’t “live informed, disciplined lives”(read: less well-educated and poorer.) The righteous would rather see that money funneled into products that would provide them with “better hair, skin and sex,” Stern suggests.  For a more generous synopsis of Huber’s argument, see H.G. Stern’s rave review on Insureblog. 

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Human Growth Hormone and The Business of Immortality

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Last week, James Forsythe, a prominent doctor in Reno, Nevada was acquitted by a federal jury after going to trial on allegations that he trafficked in human growth hormone (HGH). The decision came as a relief to the American Academy of Anti-Aging Medicine (A4M), because among other allegations, the doctor was accused of selling HGH as an anti-aging treatment, which is illegal in the U.S. A4M has a history of pushing for HGH-driven anti-aging treatments.

So what’s so special about HGH when it comes to aging? Beginning in your 40s, the pituitary gland slowly reduces the amount of hormone it produces, a fact that some feel is both responsible for the frailty of age and reversible through the introduction of synthetic growth hormones.

But there is little, if any, reliable scientific evidence about the anti-aging benefits of HGH. In fact, there are no double-blind placebo-controlled studies for most of the anti-aging miracle cures out there. Yet we do know for a fact that HGH can increase the risk of cancer—not to mention edema (retention of fluids), arthralgia (joint pain), carpal tunnel syndrome, diabetes, and gynecomastia (enlarged mammary glands in males).  Oh, and it might actually shorten life.

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Disease Mongering By Way of Restless Legs

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Yesterday during lunch I saw an ad for Mirapex, a “prescription medicine used in
the treatment of moderate to severe primary restless legs syndrome (RLS).” The
fact that there was such thing as a restless leg syndrome seemed odd to me, so
I did some sleuthing. (Maggie, who has in fact discussed RLS over at the Health Care Blog, has some great
thoughts on the issue as well.)

 RLS is a “medical condition that is described as an urge to
move the legs”—simple enough. The Mirapex website offers a list of question
designed to help you diagnose yourself:

  • Do you feel a strong desire to move your legs from time to time, often when they make you uncomfortable?
  • Do those sensations in your legs occur or get stronger when you are inactive?
  • Does moving around or stretching help ease those uncomfortable sensations in your legs?
  • Do those uncomfortable sensations feel their worst at night?

Boehringer
Ingelheim Pharmaceuticals, the manufacturer of Mirapex, is considerate enough
to translate these symptoms into layman’s terms:

People often use words like
"burning," "creeping," "crawling,"
"aching," "tingling," and/or "tugging" to try and
describe their symptoms. Many people with restless legs syndrome have
difficulty explaining the odd sensations they feel, even when talking to their
doctor.

So far it seems that I may have RLS if my (1) legs get uncomfortable after
sitting for a while and (2) I have trouble articulating this sensation. By
these criteria, most anyone who has uttered the phrase “my leg feels weird”
qualifies as an RLS sufferer.

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We Can’t Fund SCHIP, But We Can Save Merck

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Today, Bloomberg trumpeted the good news:  “Merck Profit Gains on Cancer Vaccine, Diabetes Pill.”

“Merck & Co., the third-largest U.S. drugmaker, reported a 63 percent gain in earnings,” Bloomberg reported, a victory made doubly by the fact that Merck has seen some rough times. “Competition from generics and the withdrawal of the pain pill Vioxx in 2004 over heart risks have pulled net income down 39 percent since 2001,” the story explained. Indeed, Vioxx gave Merck a black eye, and it’s still battling lawsuits in the courts. But Gardasil, Merck’s new vaccine to prevent cervical cancer, is turning out to be just the blockbuster the company needed. “Gardasil, introduced a year ago [already] has sales of $418 million”

Those of you familiar with my views on Gardasil may want to skip the below section, as it is pulled from an August post. I promise I won’t do this often, but this is an important subject and it’s example of how, if drug manufacturers and their lobbyists work quickly enough, they can sell their story to politicians and to the public before skeptics in the scientific community have a chance to weigh in. Remember the drug industry saying: “It’s important to sell a new drug while it’s still effective” (i.e. before people know too much about it).

On August 27, I wrote:

Earlier this month the FDA announced that the direct-to-consumer ads Merck has been using peddle its new cervical cancer vaccine, Gardasil, are “half-true . . .information currently being advertised could mislead the public.” 

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The FDA’s Moment of Truth by Niko Karvounis

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Soon we’ll see what the FDA is made of.

Yesterday the AP reported that “doctors told the Food and Drug Administration advisers that the over-the-counter [cough and cold] medicines shouldn’t be given to children younger than 6 because they don’t help them and aren’t safe.” The final recommendation of an advisory panel of outside experts tasked with determining whether or not this is the case is due to the FDA late today.

By “not safe” petitioners don’t necessarily mean that the medicines themselves cause harm, but that they encourage reliance on “quick fixes,” an approach that can mask symptoms of more serious ailments.

This is obviously a problem in and of itself, but becomes an even a bigger deal when one considers that there are no known benefits to the medication. The drugs have never been tested on children—something the FDA has known since 1972. Instead, drug makers “have used extrapolated data from studies in adults to come up with dosing recommendations based on a child’s age or size.” Hardly rigorous medical science.

The threshold for unacceptable risk is a lot lower when a medicine does nothing. Michael Shannon from the Children’s Hospital Boston pediatrician and Harvard Medical School puts it best: “when a treatment is ineffective, its risks — if not zero — always will exceed its benefits.”

So what should worried parents do when their kids have a cold?

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Do You Want to Know That You Will Be an Alzheimer Patient in Two to Six years?

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Yesterday The New York Times reported a medical breakthrough: “the development of a blood test that can  accurately  diagnose Alzheimer’s disease, and even do so years before truly debilitating memory loss.”

Well, “accurately” may be a bit of a stretch. As the Times explained, the test is about “90 percent accurate in distinguishing the blood of people with Alzheimer’s from the blood of those without the disease” and “about 80 percent accurate in predicting which patients with mild memory loss would go on to develop Alzheimer’s disease two to six years later.”

Then, the Times acknowledged, there is one other problem with the test:  “At present, treatments for Alzheimer’s disease are not very effective.”

So why exactly would I want an early warning that would give me two to six years to contemplate what it will be like to observe my mind dissolving? (Of course I could comfort myself with the fact that the test is only 80 percent accurate, but somehow I suspect that would only compound my anxieties.)

“There are people who want to know what their future holds so they can plan their estates and lives,” Dr. Sam Gandy, a professor at Mount Sinai School of Medicine in New York who is chairman of the medical and scientific advisory council of the Alzheimer’s Association, told the Times.

Right, this is an estate planning tool.

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Inside the FDA

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I was speaking to a source inside the FDA recently and he explained that since the FDA has committed to reviewing applications for approval of a new drug within 10 months, drug-makers have been submitting “shabbier” applications that contain less evidence about risks and benefits.

“For the drug-maker it’s a gamble. The company is betting that, because we want to make the 10-month deadline, we won’t send the application back,” said the source. And often, he acknowledged, the drug-maker is right. “If you find a problem or there is something missing and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process.”

In the past, he adds, a company submitting an application knew that if the application wasn’t up to snuff, the FDA would send it back. But those standards have fallen: “Now we send it back [only] if it’s really crappy.”

We also talked about direct-to-consumer advertising and why many in the pharmaceutical industry resisted the suggestion that they wait two years before trying to sell a new drug directly to the public. “There is a saying in the industry,” he confided, “[that] you want to get doctors accustomed to using a new drug while it still ‘works’—while it’s still the latest and the greatest.”

In other words, drug-makers want doctors to begin using the drug before everyone discovers that it is not quite the miracle cure that some hoped it would be. Knowing that it takes time to discover the risks of a drug, doctors might not be so quick to take up the absolute newest thing on their own. That’s why companies like to go to consumers who they hope will push their doctors into trying the new products before all the risks are known.

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