Category Archives: Pharmaceutical

Obama Wins Round One of Budget Negotiations

Posted on by

CNN is reporting that the “Fiscal cliff deal is down to wrangling over the details.” While others in the media continue to say that talks are stalled, everything I know about both the economics and the politics of the situation tells me that CNN is right.

At 4:30 this afternoon, CNN updated its story: “Both sides agree the wealthy will pay more, so now fiscal cliff  talks come down to how much Republicans can wring out of the White House in return for giving in on taxes.

“To President Barack Obama, it’s all about first locking in additional revenue from raising taxes on high-income owners, an outcome the GOP has long rejected.”

President Obama had made it clear that negotiations over government spending on safety nets such as Medicare wouldn’t begin until Republicans accepted a higher marginal tax rate for individuals earning over $200,000 and couples earning over $250,000.

The president dug in, and, according to CNN, he has won round one.

“Retiring Republican Rep. Steve LaTourette of Ohio told CNN on Thursday that he sensed a shift in the House GOP approach during a conference meeting the day before.

“A GOP source told CNN that talks between staff members on both sides resumed Thursday for the first time this week, after Obama and Boehner spoke by phone the day before.”

A Two-Step Approach

It is not clear whether negotiations over so-called “entitlements” will be concluded before the end of the year. But CNN, reports

“All signs point toward a two-step approach sought by newly re-elected Obama — an initial agreement that would extend lower tax rates for income up to $250,000 for families, while letting rates return to higher levels from the Clinton era on income above that threshold.”  That agreement on taxes will be signed and sealed before the end of the year.

“Even conservatives such as Oklahoma Sen. Tom Coburn and Louisiana Gov. Bobby Jindal acknowledge the obvious — taxes on the wealthy are going up despite opposition by Republicans.

“‘Whatever deal is reached is going to contain elements that are detrimental to our economy,’ Jindal wrote Thursday in an opinion piece published by Politico. ‘Elections have consequences, and the country is going to feel those consequences soon.’”

Continue reading →

8 COMMENTS SO FAR -- ADD ONE

Are Americans Working Health Care into the Ground?

Posted on by

We Americans are proud of our work ethic. We work longer hours, and more productively, than any other nation. Our industriousness has long been cited as a source of strength of our economy—but it just might be a source of some of our health care woes as well. 

According to a just-released study from Wake Forest University, professional flexibility is an important contributor to better health. Employees at all levels who have, or feel they have, more job flexibility (e.g. the ability to work from home, choose their hours, etc.) engage in healthier behavior than those that don’t. The study found that employees with flexible schedules exercised more, attended more employer-sponsored health classes, were more likely to describe themselves as living a healthy lifestyle, and reported getting more sleep. When the researchers checked in a year later, they found that as job flexibility improved, so did healthy habits: more flexibility meant more sleep, more health classes, and a healthier lifestyle.

This study deserves attention. Changing behavior is the single most powerful way to prevent health problems. As experts from the Robert Wood Johnson Foundation noted in a Health Affairs article earlier this year, “behavioral issues represent the greatest single domain of influence on the health of the U.S. population,” with 40 percent of early deaths in the U.S. due to behavioral patterns. Anything that promotes health behavior needs to be seriously considered as a strategy for making America healthier—and by extension, health care costs lower. 

Obviously, somehow ensuring that everyone in America had more flexible hours wouldn’t cut early deaths by 40 percent. And there’s no guarantee that more flexible hours will translate into better sleep, more exercise, or more education on a national scale. Any movement for universal job flexibility would have to be coupled with a concerted effort to translate free time into healthy time.

But this study gets us thinking about behavior as more than just the usual spate of no-nos like smoking or eating poorly. Work is behavior. Work is relevant to health—more so even, than the Wake Forest University study suggests. There’s an argument to be made that more job flexibility can translate into a shift away from medication in two big arenas: childhood disorders and depression.

Continue reading →

13 COMMENTS SO FAR -- ADD ONE

The FDA: What Happens When You Starve the Beast

Posted on by

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.

Continue reading →

17 COMMENTS SO FAR -- ADD ONE

How the Media Covers Health Care

Posted on by

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”:

Continue reading →

11 COMMENTS SO FAR -- ADD ONE

ADHD and the Medication Feeding Frenzy in America

Posted on by

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.

———————————————-

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.

Continue reading →

15 COMMENTS SO FAR -- ADD ONE

Desperate, Drug Makers Court Doctors in Developing Countries

Posted on by

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.

Continue reading →

4 COMMENTS SO FAR -- ADD ONE

Health Beat Hosts Health Wonk Review

Posted on by

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. 

Continue reading →

10 COMMENTS SO FAR -- ADD ONE

Autism—Another Epidemic?

Posted on by

Does your 6-month old make eye contact?  Does your 8-month old follow your gaze? Does he mimic your facial expression if you show fear, anger or pleasure?

If you answered “no” to these questions, the American Academy of Pediatricians (AAP) wants you to know that your child might be suffering from Autism Spectrum Disorder (ASD). Just two weeks ago the Academy sounded the alarm in a report calling for screening of children under two, listing signs of autism which pediatricians and parents should watch for. The report appeared in the November issue of the journal Pediatrics and on the group’s website.

At one time, autism was considered a rare disease. When I hear the word, I think of Dustin Hoffman’s brilliant performance in “Rain Man,” where he acts the part of an obsessive-compulsive idiot savant, imprisoned in his own tiny world of repetitive behavior. Rain Man is almost incapable of social interaction; it seems clear that he is afflicted with an uncommon disorder. But the Academy’s report begins by warning that, today, autism is not rare. One out of 150 children suffers from ASD, we are told. That’s why it is important to begin screening for the disease at an early age.

According to the AAP, doctors and parents should keep an eye on even the youngest children. For example, the report explains that “turning consistently to respond to one’s own name is an early skill that parents should expect to see in an 8 to 10-month old.”  The absence of this skill is said to be an autism warning sign. Other signs of trouble include “lack of warm, joyful expressions” when the parent points to an object and the baby gazes at it.  And by 9 months, says the report, the baby should be babbling—otherwise parents should be worried.

The AAP offers a brochure, entitled “Is Your One-Year-Old Communicating
with You?”, developed to help raise parent and physician awareness and
to promote recognition of ASD symptoms before 18 months of age. (The
AAP advises that pediatricians give the brochure all parents at the
child’s 9 or 12-month visit.) Different children “present” differently,
the report observes, but some particularly vigilant parents may still
be able to “perceive that their child is ‘different’ during the first
few months of life.”

Continue reading →

8 COMMENTS SO FAR -- ADD ONE

Human Growth Hormone and The Business of Immortality

Posted on by

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.

Continue reading →

11 COMMENTS SO FAR -- ADD ONE

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

Posted on by

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.

Continue reading →

16 COMMENTS SO FAR -- ADD ONE