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 #266 for November 11th, 2009: Spirit of Cooperation or Drug Companies Setting Competition Aside For Patient Safety

It’s rare that competing drug companies team together to work on a common problem. But that’s just what Biogen, Elan, and Roche are doing right now. The problem is a condition called progressive multifocal leukoencephalopathy (PML) and two different drugs have been found to increase the risk of the rare neurological condition. So these three drugmakers are coming together and sharing data to find out why their drugs might be causing PML in some patients.

The drug Tysabri, which is used to treat multiple sclerosis, is sold by under a joint venture between Biogen and Elan but was taken off the market this year because of its link to PML. Also pulled this year due to ties to PML was Roche’s psoriasis drug Raptiva. The drugmakers involved will create a global database of PML cases that will be used to predict, prevent, and treat infections. While their motivation for this collaboration might be driven in part by a desire to get their drugs back on the market, it’s still nice to see drug companies put patients ahead of secrecy and competition. More of these collaborations would be welcome in the future, whenever multiple drugs are linked to a common debilitating side effect.

Read more about this in the Wall St Journal.

Idea #250 for October 26th, 2009: Rapid Deceit or The FDA and Accelerated Drug Approvals

The FDA has a policy in place for accelerated approval of certain drugs — that is, for potentially life-saving drugs, there is a rapid approval process and then follow-up studies to ensure the drugs are working effectively. The point of the alternate process, which has been around since the early ’90s, is to make sure that drugs that may save many lives are not caught-up in an extended approval process while people die waiting for the drug. But now the GAO reports that in many cases, the FDA does not enforce the follow-up studies that are meant to prove the drugs’ effectiveness.

To wit, out of the 144 drug studies requested by the FDA, only two-thirds have been produced drug manufacturers. Fifteen of those studies have been pending for more than five years. Many of the drugs involved are intended to treat AIDS and cancer. Of course, drug companies would love to delay these studies because if the drugs are found to be ineffective, they would be pulled from the market. Under the current setup, they can continue to make money off unproven drugs — with no repercussions from the FDA.

As we’ve seen before, the FDA is lacking teeth in its enforcement of this particular aspect of the approval process. There needs to be firm rules on when studies should be completed and consequences for allowing the status to linger as “pending” for too many years. We can’t allow drug companies to buy themselves time while patients may be spending their money on drugs that don’t work — or worse, drugs that do more harm than good.

Read more about this story in the Wall St Journal and New York Times.

 

Idea #212 for September 18th, 2009: Ghostbusting or Journal Editors Try To Stop Medical Ghostwriting

This year we’ve heard about ghostwriting campaigns conducted by major drug makers to hype up their drugs in medical journals. Now some journal editors are taking steps to prevent this activity in the future, the New York Times reports. The editors want journals to adopt more stringent disclosure policies and to investigate potential articles more thoroughly.

The editorial board of Public Library of Science medical journal has called for other journals to find and expunge any ghostwritten article that has appeared in their pages. Also, any author who signed off on the ghostwritten articles should be banned from future publication, and have their activity reported to their institutions, the editorial board suggests. This comes after a senator’s inquiry into the policies of eight major medical journals found that none had ever taken action against an author partaking in ghostwriting, and some even had no policy whatsoever against the act of ghostwriting.

A study in JAMA found a ghostwriting rate of 7% in their own publication, and an 11% rate in NEJM. Since healthcare legislation may put the focus on treatments supported by evidence in research, ensuring that medical literature is free from bias is more important than ever. Effective healthcare overhaul legislation must address the issue of ghostwriting in medical journals before more lives are put at risk.

Read the article about this issue in the NY Times.

Idea #196 for September 2nd, 2009: Playing By The Rules or Government Crack Down on Illegal Drug Marketing

Pfizer agreed to a settlement with US Justice Department worth $2.3 billion over fraudulent drug marketing, making it the largest settlement with a drug company in history. The case revolves around the off-label marketing of Bextra, Geodon, Zyvox and Lyrica, and the federal investigation also found kickback payments to doctors for nine drugs. This marks Pfizer’s fourth settlement over unlawful marketing since 2002.

It is legal for doctors to prescribe medications for off-label uses, but drug makers themselves are not allowed to market drugs for uses that have not been approved by the FDA. The charges claimed that Pfizer promoted off-label uses to doctors through marketing materials and also utilized ghostwritten articles in their campaign. That the Justice Department is cracking down on a drug company to this extent for illegal activity is promising. One has to wonder how many other violations drug makers have gotten away with in years past. The only way these companies can be deterred is through fines in the magnitude of billions, so the Justice Department is definitely sending a message here.

You can read more about this story here.

Idea #177 for August 14th, 2009: Bitter Pill or Making Painkillers Harder to Abuse

An interesting new drug won approval from the FDA yesterday that may be a step towards making narcotics less addictive. The drug, Embeda, is an extended release morphine pill that has been designed to be difficult to abuse. Many prescription pill abusers crush, inject, or dissolve pills rather than swallow them, in order to get a faster and more intense effect. Embeda, though, contains a core made of naltrexone, an opioid antagonist that will block the euphoric effects of morphine. When ingested normally, the morphine is absorbed but the naltrexone passes through the body, allowing the morphine to take effect. However, if crushed or dissolved, the naltrexone is released and will, in theory, block morphine’s effect.

About 5 million Americans misuse prescription pain meds, and 5% of high school seniors admit to have abused OxyContin at some point. Those numbers have pushed drug companies to find new ways to make the painkillers less appealing to addicts. At least two other drugs that will function in a similar way are awaiting approval from the FDA currently. But the drugs may not be completely effective in their anti-abuse goals. Clinical trials of Embeda indicated users were less likely to receive euphoric results when the drug was crushed, however, the company that produces it admits that there is no evidence the drug is less likely to be abused. One also has to wonder if making narcotics less effective will just drive abusers to take greater quantities, which could result in overdoses. But if they truly do reduce the potential for abuse, this new wave of narcotics may cut down on the number of teen addicts.

Read more about the approval of the drug in Bloomberg and in the Wall St Journal.

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 #167 for August 4th, 2009: Faking It or Wyeth Accused of Ghostwriting Journal Articles

The influence of ghostwriters in medical journals is broader than previously thought, says a story in the New York Times. The drug maker Wyeth allegedly paid ghostwriters to author 26 papers between 1998 and 2005 that hyped the use of hormone therapy in women. At the same time, Wyeth’s hormone drugs Premarin and Prempro saw increased sales, peaking in 2001 with $2 billion. In 2002, federal researchers linked the use of hormone therapy drugs to ailments like breast cancer, and sales of the drugs have been dwindling since.

The ghostwriting process usually began with Wyeth outlining and drafting articles, then enlisting doctors to contribute and sign their names to the articles, and in some cases the doctors contributed nothing at all except their byline. The papers would have to undergo the same review process that any other medical paper undergoes, but the editors were never made aware of the fact that Wyeth was involved in the authoring of the manuscripts. The papers would appear in journals, where they could influence the prescribing habits of physicians who read them.

This whole fiasco is disturbing on a number of levels. For one, it’s a breech of the scientific process, where authors and researchers are expected to be intellectually honest and free from bias or outside influence. In the case of prescription drugs, incorrect data could end up risking lives of future patients prescribed those medications. Any physician found to be a part of this scheme should be severely reprimanded, and certainly be banned from any sort of publication in the future. Drug companies that are guilty of this behavior should be prosecuted. These bogus articles may have led to patient deaths. It’s vital that drug companies are deterred against similar schemes going forward.

See the story in the NY Times about this issue.

Idea #163 for July 31st, 2009: Sunlight Is The Best Disinfectant or Eli Lilly Discloses Registry of Doctor Payments

Earlier this year, under mounting pressure from the Obama administration, industries in the health field including drug companies promised to make some concessions to do their part in reforming healthcare. Eli Lilly announced this month they will publish a registry of doctors who served as paid consultants during the first quarter of this year. A total of $22 million went to those providers earlier this year, with the average consultant making about $1000.

Payments to doctors by drug makers, device makers, and other industry groups always create the perception of conflict of interest. In the past few years, Eli Lilly has disclosed some of its other financial dealings like grants to non-profits and academic institutions. Increased transparency is always welcomed. This may be just the start of more concessions made by those in the healthcare industry in the coming months. Patients should be able, in the near future, to search for providers’ dealings with industry when deciding who to seek for treatment.

Read more about this in the Wall St Journal, and see Eli Lilly’s registry here.

Idea #128 for June 26th, 2009: Dangerous “Liaisons” or Drug Companies and Medical Science Liaisons

According to FDA rules, drug companies are not allowed to promote off-label uses for their products. So to get around that legal roadblock, they’ve been using “medical science liaisons” to do that work instead. Because they’re not technically sales staff, medical liaisons can visit doctors on drug companies’ behalves and fill them in on off-label, unapproved uses for the drugs. At the same time that drug companies are shedding sales staff, they are hiring more and more medical science liaisons; the number grew by 48% between 2003 and 2008.

Industry groups contend that the liaisons’ role is one of educating providers and not sales. Unlike sales reps, liaisons are not given incentives for driving up sales, according to drug companies. But it’s hard to see this as anything other than an attempt to exploit a loophole in the law that prevents drug companies from promoting off-label uses. The rule, keep in mind, is in place for a reason: to protect patients from the influence that drug companies may have over providers. Until the loophole is closed, there is still a greater risk that drug companies are affecting the way providers are prescribing drugs.

Read more about the issue in the Wall Street Journal.