A New Team at the FDA -- Sharfstein's Critics

Over the week-end, when I heard that President Obama had selected Margaret  Hamburg as FDA commissioner and Joshua Sharfstein as deputy commissioner, I began Googling “Sharfstein.”  I already had read about Hamburg and I knew the former New York City health commissioner has earned very high marks. 

But I didn’t know much about Sharfstein. So my heart sank when I read this in the “Comment” section of yesterday’s Guardian: “Although Dr Margaret Hamburg, the nominee for commissioner, boasts significant experience in government and is highly thought of in the public health community, her new deputy, Dr. Joshua Sharfstein, is an inconceivably poor choice.”

Reportedly, Sharfstein is going to be the point man regulating drugs and devices. Meanwhile Hamburg  will ovesee food safety and tobacco—if the agency wins some control over the substance. (According to the Wall Street Journal, a bill that puts tobacco under FDA regulation seems poised for passage next session).  Given how the FDA’s work will be divided, Sharfstein’s appointment becomes extremely important. Indeed,  the “Comment” in the Guardian notes: “from the vantage point of industry and patients, this would make Sharfstein a far more influential figure than his nominal boss – but without requiring confirmation by the Senate.” Here they seem to be implying that the Obama administration is trying to slip a weak candidate past the Senate.

But then the article’s authors, Jeff Stier and Henry Miller set out to explain why they object to Sharfstein. And at this point, I begin to smile.They portray Pharma as an industry that has been bullied, by the government and the press: “The new FDA leadership must  confront a trend that has become popular – especially among members of Congress and the media – of vilifying drug companies, and even alleging that regulators have become too cosy with industry.”  Imagine that.

The FDA: What Happens When You Starve the Beast

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.

How the Media Covers Health Care

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”:

The New York Times “Gets Cracking” on Rising Health Care Costs

On Sunday the New York Times published an editorial that set out to analyze “The High Cost of Health Care.” The result might best be described as “muddled.”

What is exasperating is that about 85 percent of the facts in the editorial are true. But a good 15 percent are simply wrong.  And the Times’ editors managed to weave truth and error together in such a way that it would take a knitting needle to separate the two. As Matthew Holt put it on The Health Care Blog: “the piece looks entirely as though it was written by a committee that couldn't agree with itself.”

As you read the editorial, you can almost see the editors sitting around a table, negotiating. “Okay,  we’ll let that sentence about the value we’re getting for our dollars stand—as long as well keep this sentence about  ‘skin in the game.’”  The result, a mix of propaganda and analysis, is far more dangerous than outright lies because the many true facts make the whole thing sound credible.   

Because I hate to see our paper of record disseminate disinformation, I am going to try to separate the wheat from the chaff. Begin with the truth: Near the top of the story, under a sub-head that reads “Varied and Deep-Rooted,”  the Times provides a nice summary of the main reasons why we lay out roughly twice as much as the average developed nation, without getting care that is twice as good:

“we pay hospitals and doctors more than most other countries do. We rely more on costly specialists, who overuse advanced technologies, like CT scans and M.R.I. machines, and who resort to costly surgical or medical procedures a lot more than doctors in other countries do. Perverse insurance incentives entice doctors and patients to use expensive medical services more than is warranted. And our fragmented array of insurers and providers eats up a lot of money in administrative costs, marketing expenses and profits that do not afflict government-run systems abroad.”

Spot on. If only this section of the editorial had not begun with a casual half-truth: “Contrary to popular beliefs, this is not a problem driven mainly by the aging of the baby boom generation, or the high cost of prescription drugs, or medical malpractice litigation that spawns defensive medicine.”

They first part of the sentence is correct: the aging of the boomers is not a major cause of health care inflation.  The last clause of the sentence is debatable, though probably true.
What’s troubling is the middle clause:  Why does the Times feel obliged to declare that the “high cost of prescription drugs” is not an important factor behind soaring medical bills?

How Wall Street Reacts to Fraud in Our Health Care Industry

This appeared on Bloomberg News today:

“WellCare Shares Jump After Analyst Calls Fraud Probe `Limited'

Nov. 20 (Bloomberg) – WellCare Health Plans Inc., the U.S. health insurer under investigation for possible government overpayments, rose the most in two weeks in New York trading after an analyst upgraded the company.

“The analyst, Carl McDonald of CIBC World Markets in New York, called the probe ‘limited’ and raised his rating of WellCare to ‘sector outperform-speculative' from ‘sector perform.' WellCare rose $2.38, or 6.8 percent, to $37.39 at 9:40 a.m. in New York Stock Exchange composite trading after touching $38.14.

“A U.S. government raid of WellCare's Tampa, Florida, headquarters on Oct. 24 yielded thousands of records, including papers pulled from a shredder bin and files on offshore bank accounts, according to court filings. McDonald said the filings suggest the probe is focused on Florida's Medicaid program for the poor.

“’It's possible that the Florida Medicaid investigation spreads into other areas, but the document seems to rule out widespread, systemic fraud,’ the analyst said in a note to clients today.”

Bloomberg also reveals that: “The agents seized records from the desks of Chief Executive Officer Todd Farha and Chief Financial Officer Paul Behrens, according to the court records. From Behrens' desk, agents grabbed a document called the ‘Stairway to Heaven Plan,' according to the inventory.

“Also taken were wire transfers, tax returns, bank accounts in the Grand Cayman Islands, a calendar of political visitors and contributions, and phone lists. One seized document was labeled ‘Re: Possible Kickback,’ according to the court records”.

Yet none of this seems to bother the analyst who upgraded the stock or the many investors who followed his upgrade--pushing the share price up 6.8 percent this morning.  The analyst predicts that “that WellCare [will] settle, pay a fine, but remain in all its businesses, rather than being put out of business.”

ADHD and the Medication Feeding Frenzy in America

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.

Desperate, Drug Makers Court Doctors in Developing Countries

In the U.S. we are accustomed to seeing exceptionally well-dressed drug company reps strolling into doctors’ offices bearing trinkets: coffee cups, note pads and pens. We also know that they take doctors to expensive dinners, and host “continuing education” junkets to warm climes. Device-makers have been known to ferry doctors to strip clubs after dinner.

But in the developing world, drug makers are pulling out all of the stops. Often there is not even a pretense that the gift will help the doctor do his job. In Kashmiri, a physician confides, “representatives of pharmaceutical  companies offer cash, refrigerators, color televisions, laptops, PCs, mobile phones, ovens, phone bills, [and even to pay school] tuition [for your] children.”

In India, a doctor from Mumbai reports:  “On sale of 1,000 samples of the drug, you get a Motorola handset. On sale of 5,000 samples you get an air cooler. On sale of 10,000 samples get a motor bike.”

In Pakistan, a survey of 149 doctors, 100 medical information officers (sales representatives) and 99 medical store personnel, found that gifts may include included air conditioners, cars, cash, home appliances and domestic cattle.   Murad M. Khan, professor & chairman of the department of psychiatry at Aga Khan University, describes the latest practice: For writing 200 prescriptions of a company’s high-priced drug, a doctor is rewarded with the down payment on a brand new car.

These are just a few of the enticements documented in a November 2007 Consumers International (CI ) study, "Drugs, Doctors and Dinners: How Drug Companies Influence Health in the Developing World." (Thanks to Gary Schwitzer, at Schwitzer Health News Blog, for calling attention to this report.) A global voice for consumers, CI is an independent not-for-profit boasting over 220 member organizations in 115 countries.

Human Growth Hormone and The Business of Immortality

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.

When the Government Does What Drug-Makers Won’t Do

Today, Bloomberg News reported that “Deadly Staph Germs May Be Cured by Old, $1-a-Day Antibiotics.” It turns out that generic, World War II-era antibiotics are becoming “the newest weapon of choice in the fight against deadly, drug-resistant staph germs.”

Physicians have discovered that drugs costing less than $1 a day can be very effective when treating methicillin-resistant Staphylococcus aureus, known as MRSA. The bacteria, once found only in hospitals and nursing homes, recently made news by showing up in schools and gyms. Last month, MRSA was linked to the deaths of a student in New York and one in Virginia.  Annually, more than 18,000 Americans are killed by MRSA.

The physicians who mounted the studies of the older drugs were funded by the federal government. Meanwhile, in the for-profit private sector, Bloomberg observes, “drug-makers are spending hundreds of millions developing medicines that cost more than $100 a day to treat advanced cases.”

But physicians know the older, cheaper drugs work. “We have used these older drugs with success for years,'' says Gregory Moran, one of the study leaders. He is a professor of emergency medicine at the Olive View-UCLA Medical Center in Sylmar, California, affiliated with the University of California at Los Angeles.

Disease Mongering By Way of Restless Legs

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.