Idea #315 for December 30th, 2009: Passing Muster or Stricter Device Approval Guidelines At The FDA

The FDA has announced plans to implement a more strict process for the approval of medical devices. This decision comes after several journal articles brought to light flaws in the current approval process. For instance, an article in JAMA showed that the approvals of a number of cardiovascular devices in the last decade were based on a single study. Also, only about half of the outcomes in the studies were compared to control groups. Rigor has certainly been lacking in these FDA approvals. It might be a case of too little, too late, but at least the FDA has admitted to the problem and will make an effort to address it.

Read more about this story here.

Idea #289 for December 4th, 2009: Playing With Fire or FDA Looking At Side Effects of Antipsychotic Drugs on Children

A group of drugs called atypical antipsychotics are widely used to treat a number of psychiatric conditions including schizophrenia and depression. They are sometimes prescribed to children, but the FDA is now asking for further study on the matter. Research has shown that children who take these drugs are at increased risk of experiencing adverse metabolic side effects.

Metabolic side effects include problems like weight gain, high blood pressure, diabetes, and high cholesterol. There is also the larger debate regarding these medications and whether young children should be given powerful antipsychotic drugs in the first place. Increasingly, children are being prescribed these drugs for unapproved uses, like for treating ADHD, without knowing the long-term effects they may have. The FDA should take a good look at how these drugs are prescribed, their side effects, and whether the benefits outweigh the mounting negatives associated with them.

Read more about this issue here.

Idea #269 for November 14th, 2009: Something’s Brewing or FDA Looks To Ban Caffeinated Alcoholic Beverages

Popular new products that combine alcoholic beverages with caffeine have come under scrutiny for the health risks associated with their consumption. In young people, for instance, the products can cause increased risk taking behavior and result in more car crashes and physical violence, among other detrimental behavior. It’s believed that the caffeine masks the depressant effects of alcohol and can cause users to misjudge their intoxication level. Now the FDA is taking steps to regulate these products.

As a result of the recent scrutiny, Anheuser-Busch and Miller-Coors have altered ingredients and pulled caffeine-containing products from the market. Still, many other companies continue to sell similar products today. The FDA has now sent notices to 30 of those companies, giving them 30 days to prove that their products are indeed safe. Combining caffeine and alcohol has not been approved by the FDA at this point. If companies cannot provide evidence that their products are safe, the FDA is expected to take steps to ban the beverages. It’s unlikely that companies will be able to prove the products’ safety, which is good news for those concerned about an increase in risky behavior by a young adult population.

Read more about this story in the LA Times.

Idea #174 for August 11th, 2009: Comparing Apples and Apples or Comparative Effectiveness Data on Drug Labels

The labeling on drug packages has become an issue in recent months. Now an essay in the New England Journal of Medicine is promoting the idea of including comparative effectiveness data on drug labels. Pharmaceutical companies generally test new drugs against placebos when assessing their efficacy. While a new drug may perform significantly better than a placebo, they are often not tested against other similar drugs on the market. It’s beneficial for drug companies not to mention that information when marketing a drug, but consumers would be in a better position if they were aware of a drug’s effectiveness compared to similar products.

When consumers see advertising for a new drug, they generally assume that it is more effective than existing drugs at treating the same condition. However, most new drugs do not offer vast improvements in effectiveness over previous drugs. Drug companies would likely fight any action by the FDA to require a change in labeling that includes comparative effectiveness because consumers would not pay for a costlier drug that is no more effective than what is already on the market. In the end, the FDA should make decisions that will inform and protect the consumer, and comparative effectiveness labeling certainly makes sense as a means of better informing the public on the drugs they buy.

See more about this in the LA Times and the NEJM.

Idea #106 for June 4th, 2009: Changing Their Minds? or FDA Revisiting Toxic Plastic in Baby Bottles

In a previous post I covered the dangers that Bisphenol-A, a component of some plastics, poses to babies who drink from bottles made of the substance, while the FDA continues to stand behind its safety. I wrote, “At the very least, the FDA should reevaluate its conclusions that were based on biased studies.” Well, it looks like the FDA is poised to do just that, the Wall Street Journal reports. The FDA’s chief scientist has been assigned to reevaluate the safety of BPA in baby bottles, under the new leadership of FDA head Margaret Hamburg.

Several states and cities have already taken steps to ban BPA-containing baby bottles in their communities, and a number of bottle manufacturers have dropped BPA from their production. Yet the FDA has been steadfast in its assertion that bottles made from BPA pose no significant threat to babies. The chemical has been linked to numerous health problems like cancer and diabetes, but the FDA based its flawed decision on industry-funded research, which is unthinkable. Luckily, the FDA is taking a new direction with Hamburg at the helm. In the future, BPA shouldn’t have a place in any food container. But for now, we must keep it away from babies at the very least.

For more on the matter, read this attorney blog and this Washington Post article about the shady ways some manufacturers are trying to convince the public on BPA’s safety.

Idea #105 for June 3rd, 2009: Lifting the Veil of Secrecy or Transparency at the FDA

Some more promising news out of the FDA: they’ve created a task force that will look out how the agency can increase their transparency. As it stands now, details on the FDA’s decision making process for drug and device approval may be hidden under a shroud of “trade secrecy.” The danger is, without disclosing clinical trial details, some drugs may be perceived as more effective than they are in reality, and complete information about their safety may not be available to the public.

The New York Times cites three examples where that secrecy has prevented the FDA from releasing valuable information to the public: a popular heartburn drug was known to be toxic to babies, a diabetes drug and a pain-killer increased the risk of heart attack, and antidepressants were linked to increased suicides in teens. In each case, a more transparency could have saved lives. It seems like the FDA is opting to protect manufacturers’ trade secrets over ensuring Americans’ health.

For transparency to come about, existing laws will need to be rewritten and multiple Congressional committees will have to be involved. But this is too important a reform to be ignored or abandoned. The FDA for too long has sided with the interests of industry over the interests of the public. This could be the start of a promising shift in the FDA’s priorities concerning industry trade secrets.

In the media, see this editorial in the NY Times, this story in Forbes and this story in USA Today

Idea #98 for May 27th, 2009: Nowhere To Go But Up or Change at the FDA

The new leadership at the FDA is promising to change the way the organization operates, along with changing the way success should be defined. In an essay published in the New England Journal of Medicine, new FDA head Margaret Hamburg wrote that “the ultimate measures of the FDA’s success should reflect its fundamental goals and go beyond such intermediate measures as the number of facilities inspected or drugs approved.” The new leadership is making it clear that the primary concern of the FDA should be Americans’ health, not industry (as it seemed to be in the past).

Regarding food safety, Hamburg wants the FDA to focus on prevention of foodborne illness instead of simply reacting after the fact, as they tend to do now. Also, they want to be able to work closer with the USDA on the matter, which has been a source of trouble in the past. Outside of food safety, the FDA now plans to work closer with the CDC on matters such as swine flu. Inter-agency cooperation has been difficult in the past, and getting by that obstacle would certainly make the FDA more effective.

Given their failures in the past, it’s a positive development that the FDA now seems to be learning from debacles like the salmonella outbreak in peanuts last year. The FDA has a long way to go before the public regains confidence in the organization. It’s refreshing to hear that the they are taking a new approach, but whether the promised changes will come to fruition is still up in the air. We’ll see how much of that idealism fades with the realities of bureaucracy and private interests.

In the media, see: the Wall Street Journal, the AP, and the New England Journal of Medicine.