A November 7th New York Times article by Sabrina Tavernise discusses the recent FDA ruling surrounding trans fats.

Nutrition is an ever-changing area of research.  Many of the guides to healthy cooking and eating methods once thought ideal are now seen to be quite unhealthy and harmful to our health.  During the 1950’s, 1960’s, and 1970’s, trans fats exploded onto the American scene and were heavily used in major food chains and in popular foods we ate.  And this made economic sense: saturated fats such as butter (animal fat), are more expensive than partially hydrogenated oils (trans fats).

Now, heart disease as the leading cause of death in the United States, and health consciousness is becoming increasingly popular.  Rightly so.  While artificial trans fats have been significantly reduced in the everyday foods Americans eat, they are still found in microwave popcorn, frozen foods, and margarine.

However, writes Tavernise, “The Food and Drug Administration proposed measures on Thursday that would all but eliminate artery-clogging, artificial trans fats from the food supply, the culmination of three decades of effort by public health advocates to get the government to take action against them.”

Some experts believe that if trans fats were eliminated in the American diet, there would be 20,000 less heart attacks each year.  Though the American populace believed for many years that trans fats were healthy and safe to use, we must rid ourselves of this notion.  Medical research has determined there is no safe level of trans fat consumption, and that trans fats carry no nutritional value.  Now, the FDA “has proposed that partially hydrogenated oils, the source of trans fats, no longer be ‘generally recognized as safe.’”

The link between trans fats and heart attack is now being further explored, and in some places the use of trans fats is already illegal.  An F.D.A ruling in 2003 required food that contains trans fats to be properly labeled as such. (Foods that contain less that 0.5 grams per serving are labeled as containing 0.0 grams of trans fat, in general.)  Not long after, cities such as Cleveland, New York, and California established a similar stance on trans fats and are encouraging the practice of banning the use and sale altogether.  The steps taken by the F.D.A and like-minded cities have already produced beneficial results.  The Center for Disease Control and Prevention has claimed the blood levels of trans fats for many Americans has been reduced.  In 2006, Americans were eating an average of 4.6 grams a day.  We now see that number is down to 1.0 gram per day.

Thankfully, the freedom of American corporations is here limited in favor of better health for all.

Julian Hattem of RegWatch, a blog curated by TheHill, reports in a piece that the US Food and Drug Administration is “not sold” on a recent pharmacy compounding bill.

The mixing and distributing of medications happens at various compound pharmacy clinics found all throughout the United States, and these compounding clinics have been the source of some recent controversies and have taken the stoplight in the medical world.  A large outbreak of fungal meningitis linked to “tainted steroid injections” from a compounding pharmacy killed 64 people this year.  More than 750 cases of infection were reported in that outbreak.

Such problems with compounding centers are not novel, but this most recent incident has pushed some to call for more federal oversight of the compounding process.  While the FDA is not necessarily looking for new responsibilities to shoulder, in light of the developing health and safety problems the Administration feels it can help create a better national standard.

FDA Commissioner Margaret Hamburg praised a bill being brought to the Senate for a vote in the coming weeks titled, “The Drug Quality and Security Act,” a bill that will hopefully help tackle some of the problems we have seen with compounding pharmacies.  Hattem states, “It would give the FDA power to regulate large compounding facilities but leave smaller plants to be overseen by state boards of pharmacy.”  Margaret Hamburg notes that the bill would not solve all the problems we are facing, but is a step in the right direction, stating “I don’t think it’s going to be as comprehensive as we initially had hoped,” but recognizes that it is “a step.”

However, the White House is not yet completely sold on the new legislation and has some concerns over the authority that will be given to the federal government with the oversight process.

According to a recent report by HealthToday.com, The U.S. Food and Drug Administration believes certain commonly-used drugs that should be more difficult to obtain.  Painkillers such as Lortab and Vicodin contain hydrocodone (a synthetic opiate) which is often abused and highly addictive; tighter controls on these types of prescriptions may be a good way to reduce the abuse seen with these painkillers.  The FDA would like to cut in half the number of prescription refills a patient can get before seeing their doctor, thus ensuring closer monitoring of both patients’ health and pharmaceutical requirements, allowing refills only for patients who truly require the drugs.

The FDA would also like to classify all prescription medications with hydrocodone as “Schedule II” medications.  The agency will begin to make that push next month, and will also seek to require that patients take their prescriptions to a pharmacy for refills, disallowing doctors the privilege of simply phoning prescriptions in.

In order for the recommendation to be used by the U.S. Drug Enforcement Administration, the U.S. Department of Health and Human Services must first approve the recommendation, and an FDA advisory panel held a vote which resulted in favor of the reclassification of hydrocodone.

The U.S. National Institutes of Health reports that one in five Americans have used prescription drugs in a recreational manner and since 2002, and that 22 million Americans have abused prescription painkillers in some way in the course of their lives.  NIH further reports that 47 million people were issued medications containing hydrocodone, filling around 131 million prescriptions.  The new classification will mean that less hydrocodone will be prescribed, and in turn, less available to be abused.  Patients will be required to visit the doctor’s office more frequently and the addition co-pays will increase health care costs.

Classifying hydrocodone as a Schedule II drug will allow the FDA to control hydrocodone in the same manner as other strong painkillers with high potential for abuse.  This push, however, is not only related to painkillers, and the ADD/ADHD drug Adderall would also face similar regulations.  The director of the agency’s Center for Drug Evaluation and Research has come out and explained that the push for this action has been driven by epidemic levels of prescription drug abuse.  Dennis Thompson of HealthToday.com believes that while the new changes may have some difficult implications for some people, the public health concerns have reached a point where something needs to be done.  I agree.

This shows that the FDA is more interested in protecting pharmaceutical companies than patients.  Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk.  A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug.  And allowing any American to use the untested drug carries more risk than the dozens or hundreds of people who would be in a test.

 

Also, note that some of these drugs are generics.  Which means that individuals injured by drugs that weren’t even tested still can’t sue the manufacturer.  And of course, there is no “fraud on the FDA” claim available…

 

  • In 2011, the FDA announced years’ worth of studies from a major drug research lab were potentially worthless.
  • About 100 drugs were on the U.S. market based in part on these tests.
  • The FDA let the drugs stay on pharmacy shelves with no new testing (in some cases until now).
  • As the FDA investigated and ordered re-tests, its European equivalent pulled seven drugs from the market.
  • The FDA says it has no evidence that any of the drugs were unsafe or that any patient has been harmed.
  • The FDA has never named the drugs, saying to do so would reveal trade secrets.
  • FDA Let Drugs Approved on Fraudulent Research Stay on the Market – ProPublica

    Here’s a little more in-depth analysis of the generic drug argument before SCOTUS:

    Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process does not mean, and should not be taken to mean, that a drug is absolutely safe even for approved uses,” said Mura, who wrote an amicus brief for AAJ in Bartlett. “Congress didn’t intend the FDA to provide the sole level of consumer protection, and a broad preemption ruling here would ignore that clear congressional intent.”

    Source:

    Supreme Court grapples with generic drugs and design defects

    On the one hand it’s disappointing to see them give up the fight.  On the other, at least this won’t lead to a SCOTUS ruling that strips the FDA of more power.  The fear of such a ruling is why I suspect the FDA gave up.

    (Reuters) – The government has dropped its push for cigarette labels to carry images of diseased lungs and other graphic health warnings, and will craft new anti-smoking ads that do not run afoul of free speech rights.

    In a letter to Republican House Speaker John Boehner last Friday, Attorney General Eric Holder said that the Food and Drug Administration would go back to the drawing board to develop the ads, as required by legislation passed by Congress in 2009.

    Source: Government changes course on graphic cigarette warnings | Reuters

    Drug marketing 101: The FDA approves drugs for specific ailments.  Drug companies may not market the drug to treat any other type of ailment.  If they do, it’s called off-label marketing and it is illegal.

    Drug marketing 201: It’s often very profitable to engage in off-label marketing, because the fines you pay are less than the money you make doing it:

    Allergan, the maker of Botox, agreed on Wednesday to pay $600 million to settle charges that it illegally promoted and sold the drug through 2005 for unapproved uses like treating headaches.

    Source: Maker of Botox Settles Inquiry on Off-Label Marketing – NYTimes.com

    Now, I don’t know for sure that off-label marketing netted Allergan more than $600 million dollars.  But, I do know that Allergan made several billion dollars selling Botox over the last few years.  $600 million is definitely a large fine, but it’s only effective if it is more money than they made by promoting it off-label.

    An analogy I often use: If you only had to give back half of the money you got from robbing a bank, how many banks would you rob?

    Did you know that the FDA doesn’t have subpoena power? That’s the power to make a company hand over a document.  Every single attorney in the U.S. can subpoena a document from a pharmaceutical company, but the FDA (which is supposed to regulate pharmaceuticals) doesn’t have that power. 

    Citing a recent spike in pharmaceutical recalls, Sen. Michael Bennet on Tuesday introduced legislation to bolster consumer protections governing the nation’s drug supply.

    * * * *

    Bennet’s proposal would update FDA data systems to track all global manufacturers feeding America’s drug supply; force companies to document each contributor to their products; grant FDA subpoena authority when conducting investigations; and empower FDA officials to recall drugs when safety issues arise — a power the agency currently has over medical device makers, but not the pharmaceutical industry.

    Supporters of the proposal are armed with a slew of statistics backing their case. Last year, for instance, the country saw a record 1,742 drug recalls, they note — a 400 percent jump over 2008. More than 100 Americans, they add, died in 2007 and 2008 from the Chinese-made blood thinner heparin. 

    Source: Senate bill would bolster drug safety requirements – The Hill’s Healthwatch

    I hope that this bill gets passed so the FDA has the tools it needs to do its job.

    This is a great step towards greater transparency:

    WASHINGTON — The Food and Drug Administration launched a website Tuesday where patients and health care professionals can find safety information about recently approved drugs and vaccines.

    On the Postmarketing Drug Safety Evaluations site, the FDA plans to share what it has learned about the safety of a new drug or biologic, such as a vaccine, 18 months after approval or after 10,000 patients have used it, whichever comes later.

    Source: New FDA website lets public find drug safety info – USATODAY.com

    Here’s the direct link.

    The bottom line is that pharmaceutical companies could put drug lawyers out of business if they just told the truth about the risks of taking specific drugs.  Instead, their marketing departments resist adding even the slightest warning to the package insert of a drug.  At least at this new site individuals will have the chance to see what kind of adverse event reports are coming in.

    I agree that visits to China should be at the top of the FDA priority list.  I’m not sure about increasing the speed of drug reviews, though, unless that speed increase comes from increased staff.  Asking existing staff to do more in less time is a recipe for another Vioxx disaster.

    NEW YORK (Reuters) – The U.S. Food and Drug Administration is working to increase the speed of drug reviews and clean up problems in the division that oversees medical devices, the agency’s commissioner said on Thursday.

    Dr. Margaret Hamburg, speaking at the Reuters Health Summit in New York, also said visiting China to discuss the safety of imported products was a top priority for her in 2010.

    Source: FDA head to speed reviews, visit China | Industry Summits | Reuters