Patient Safety Blog

Another reason for careful patients to be skeptical about overly hyped prescription drugs came this week with news about the extent to which articles in important medical journals are "ghost-written" by drug manufacturers.

According to an article in the New York Times by Natasha Singer, newly released papers from lawsuits involving Wyeth's hormone replacement drugs Premarin and Prempro show that over several years, Wyeth repeatedly hired ghost writers who placed 26 articles in 18 prestigious medical journals, all promoting the drugs in the guise of objective analysis by medical experts:

The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.

The Times article made an interesting comparison to professional baseball's steroids scandal.

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

“The filter is missing when the reader does not know that the germ of an article came from the manufacturer,” said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.

The same concern about ghostwriting applies to patients who read literature on the Internet. People can be easily misled if they think an article is truly objective.

My advice, as I write in my book, "The Life You Save," is to rely on truly independent groups like the Medical Letter and Public Citizen's Health Research Group for objective information about drugs.

Some top medical journals like the Journal of the AMA now require authors to fill out detailed forms describing exactly how much input they had into the writing of an article. But many do not have such requirements. Consumer, beware.

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Posted In: Communication , Conflicts of Interest , Medical Device Safety , Medications , Product Safety

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Acetaminophen, the unpronounceable name for the active ingredient in Tylenol, is the most widely used pain reliever in the United States. But it can destroy the liver in ordinary or near-ordinary doses. That fact is news to many consumers but is old hat to liver specialists who every week treat patients at death's door from acute liver failure due to acetaminophen.

It has now been documented that acetaminophen is the most common cause in the U.S. of acute liver failure, which can result in death if a liver transplant cannot be done.

The Food and Drug Administration has recognized that acetaminophen poisoning is a public health issue and has slowly taken steps to educate the public to this popular drug's dangers. In April 2009, the FDA mandated a new warning label, which will say on 500-mg products (Extra Strength Tylenol and its generic equivalents): “Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than eight tablets in 24 hours, the maximum daily amount.” It will also warn against using it with other acetaminophen products or with alcohol use of three or more drinks a day. The FDA rejected a request from the Tylenol manufacturer McNeil to water down the warning by removing the word “severe” and adding the word “overdose,” which the agency said could lead consumers to believe they had to greatly exceed the recommended dosage before jeopardizing their livers.

This warning won't take effect until spring 2010. FDA advisors first recommended such a liver warning in 1977.

In the meantime, an FDA advisory panel will meet in late June to consider other steps intended to make it harder to accidentally cause liver failure from taking too much acetaminophen. A "working group" of advisors has recommended among other things:

• limiting the single adult dose to a maximum of 650 mg, and limiting tablet size to 325 mg (down from the current extra-strength size of 500 mg and single dose of 1000 mg);
• lowering the maximum daily dose for adults from 4000 mg to no greater than 3250 mg (and less than that for chronic alcohol users);
• restricting pediatric liquid formulations to a single mid-strength concentration;
• eliminating acetaminophen from combination products.

You can read the working group's recommendations at the FDA's web site here.

In the 1990s, Patrick Malone was one of the first attorneys in the United States to successfully sue the Tylenol manufacturer for hiding the dangers of acetaminophen from doctors and the public. Read about his case of Benedi v. McNeil here. Watch the ABC Prime Time Live segment on this subject by clicking here.

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Posted In: Medications , Product Safety , Self-care

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One day after the FDA approved a new antiwrinkle drug (Dysport) in April 2009, the agency issued a new requirement that these drugs must carry a “black-box” warning label, the strongest safety warning typically reserved for drugs with very serious risks, Natasha Singer reports in a New York Times story. A popular antiwrinkle drug in the U.S. is Botox.

Botox and Dysport are injectable drugs developed from botulinum toxins, which temporarily paralyze the muscle into which they are injected. When administered for approved uses at approved doses, the botulinum toxins cause no harm. However, if used improperly, the toxins can travel from the injection site to other parts of the body, causing difficulty with swallowing or breathing.

Approved uses of injectable botulinum toxins include treatments for crossed eyes, eyelid spasms, severe underarm sweating, frown lines, and cervical dystonia, a neck problem that can cause severe pain and abnormal head position.

According to the new FDA requirement, the drug manufacturers not only have to add the black-box warning labels, they also have to inform doctors of the risk information in writing, and make available a medication guide to patients at the time of injection.

Patients are well advised to read all handouts on drugs they take, especially something used for cosmetic purposes. Every drug has risks and must be taken with caution.

Ten rules for safer drug use can be found at Public Citizen's Health Research Group website. These rules and more tips for safe drug use are discussed by Patrick Malone in his book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

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Posted In: Disclosure , Medications , Product Safety

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In its letters sent to 14 pharmaceutical companies in March 2009, FDA required risk information to be included in the Internet search advertisements of drugs – a move welcomed by consumer advocates, reports Stephanie Clifford in a New York Times story.

The short text ads that appear to the right of Google search results are limited to 95 characters, in which space pharmaceutical companies are now required to include not only the drug’s name but also its risk information. Although the drug companies had made risk information available just one click away from the search ads, which linked to a webpage containing detailed information of the drugs including side effects, the FDA issued this new requirement to ensure consumers are not misled.

Rita Chappelle of the FDA said in an NYT interview that it’s “vital and critical” that consumers do not mistakenly believe the drugs to be safer or more effective than they really are. This precaution is especially important in drugs that have frequently occurring or serious side effects, such as depression, liver damage, infections or severe allergic reactions.

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Posted In: Disclosure , Medications , Product Safety

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On May 1, 2009, the FDA issued a warning for consumers to immediately stop using dietary supplements containing Hydroxycut, which has been linked to dozens of serious health problems including jaundice and liver damage. The dietary supplement is also responsible for one death from liver failure. Other reported health problems include seizures, muscle damage and cardiovascular disorders.

Patients who reported health problems were taking recommended dosage of Hydroxycut products, dietary supplements for weight loss. Therefore, the FDA urges consumers to stop taking Hydroxycut products immediately to avoid risks, many of which can involve permanent damage to your health.

The agency also advises consumers to consult a doctor if they experience these symptoms: jaundice (yellowing of the skin or whites of the eyes), brown urine, nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching and loss of appetite.

Manufacturer of the dietary supplement, Iovate Health Sciences of Ontario, agreed to recall the products.

Diet supplements are promoted for their health benefits. Their “natural” ingredients are supposedly safer for a host of benefits like losing weight and gaining energy. The truth is that for most supplements, the benefits are unproven and untested, and the safety of these products is questionable.

Under federal law, diet supplements, unlike drugs, do not have to prove their safety and effectiveness before being sold to consumers. The supplement manufacturers are supposed to keep track of their own safety with very little government oversight until tragedy strikes.

Ironically, though, the diet supplements contain ingredients that mimic the actions of drugs and in some cases even contain actual prescription drug ingredients. Spiking a supplement with any prescription drug is illegal, and the FDA has been on a campaign to identify these products. Since December 2008, it has listed 70 brands of supplements that contained hidden and potentially dangerous drugs.

Another problem is that once reports start coming in of consumers sickened or injured after taking a supplement, it is often hard for safety officials to pin down what ingredient of the supplement was the culprit. Hydroxycut, for example, has a blend of a number of substances, the formula of which has changed over time. And for any of these products, because they are derived from plant materials, the strength can vary from batch to batch.

The best advice for consumers: Don’t be fooled by “natural.” When you’re taking a diet supplement, you are really ingesting a bunch of pharmacologically active substances, some of which won’t hurt you but won’t necessarily help you either. And sometimes, as with Hydroxycut, you can be hurt.

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Salmonella, which causes serious gastrointestinal illnesses that can be life-threatening, was found in pistachios last week, according to the Los Angeles Times. The FDA has issued warnings for consumers to stop eating all foods containing pistachios, while investigations are underway.

Although salmonella contamination in pistachios is yet to be confirmed, Setton Pistachio of Terra Bella Inc., the nation’s second-largest pistachio processor, has voluntarily recalled more than 2 million pounds of nuts that it shipped out last fall. Kraft Foods Inc. and Kroger have also recalled some of their pistachio products.

Consumers are advised to stop eating pistachio products and monitor the investigations as more reports become available.

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Posted In: General , Infections , Product Safety

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The U.S. Supreme Court has rejected a strong push by the pharmaceutical industry to win immunity from lawsuits filed by injured plaintiffs. In a 6-3 decision in the case of Wyeth v. Levine, the Supreme Court ruled that the Food and Drug Administration's approval of a drug's label does not mean that the manufacturer has no obligation to improve the warnings on the label if new information comes to the attention of the manufacturer.

This is a big victory for patient safety. The case will help doctors too, by keeping the pressure on the drug manufacturers to keep their product labels up-to-date so that doctors can be educated about the safest way to use drugs. Medical leaders, such as a group of editors of the New England Journal of Medicine, had filed "friends of the court" briefs urging the Supreme Court to take the side of the injured patient.

The heroic patient who pushed this case was Diana Levine, a Vermont musician who lost her arm and her career after being injected too rapidly with an anti-nausea drug called Phenergan. The drug is well known to cause terrible injuries if it gets into an artery. She contended, and the jury and the Vermont Supreme Court agreed, that the drug's manufacturer, Wyeth, knew about this risk and should have warned doctors on the label to avoid the "i.v. push" technique that carried a high risk of inadvertent injection into an artery.

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Posted In: Medical Error , Medications , Product Safety

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In a recent initiative against contaminated weight-loss products, the FDA finds 69 drugs to be contaminated with prescription drugs and chemicals, and expects the list of brands to grow even longer in the next few weeks, reports Natasha Singer of the New York Times. A complete list of the tainted drugs found so far is available on FDA’s website.

One of the best known drugs on FDA’s list is StarCaps, endorsed by many celebrities, which was found to be tainted with bumentanide, a powerful diuretic that can give rise to serious side effects. FDA’s Michael Levy said that many of the products “either contain dangerous undeclared ingredients or…have no effect at all.”

These weight-loss products are not only illegal – FDA considers a supplement unapproved if it contains an undeclared active pharmaceutical ingredient – they also pose dangerous risks for consumers. For one thing, the ingredients on their own can cause problems like elevated blood pressure or seizures. Worse, the hidden ingredients can have toxic interactions with other medications, making it difficult for doctors to diagnose patients or manage their illnesses.

Although many of the distributors of these 69 drugs have voluntarily recalled the products, others continue to sell them on the internet. Consumers taking weight-loss supplements should monitor FDA’s growing list of products they should avoid and consult their doctors for a healthy and safe weight management plan.

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Posted In: General , Medications , Product Safety , Self-care

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Seroquel is an atypical antipsychotic drug used to treat mental illnesses, such as bipolar disorder and schizophrenia. But patients who take Seroquel are 70% more likely to become diabetic than those who don’t take this drug, a risk that the drug manufacturer AstraZeneca was aware of as early as 2000. Joe Schneider and Margaret C. Fisk of Bloomberg.com report AstraZeneca’s release of its internal studies that suggested causal links between Seroquel and “diabetes and related conditions.”

Not only should patients watch out for the increased risk of diabetes that Seroquel and similar drugs (they are in a class called “atypical antipsychotics,” including Abilify, Zyprexa, and others), they need to be aware of the mental illnesses that these drugs are approved to treat. A Reuters article reports that an AstraZeneca sales representative marketed Seroquel as a depression-treating drug to a physician, which is an unapproved use of the drug. Although it is not clear from the article what dangers are associated with treating depression with Seroquel, it is safest to limit use of these powerful drugs to what they're approved to treat.

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Posted In: General , Medications , Product Safety

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The Institute for Safe Medication Practices, a watchdog group, points out that the number of deaths (4,825) and injuries (21,000) from prescription drugs have reached record levels in the first quarter of this year, representing nearly triple the number of deaths in the last quarter.

The blood thinner heparin and the anti-smoking drug varenicline are the most dangerous, according to the statistics.

And where do these statistics come from? That is the worrying part, because they are probably underestimating the reality of the situation:

The data came from voluntary reports of adverse effects to the Food and Drug Administration, which made the data public after stripping information that identified victims. Because the reporting is voluntary, researchers have speculated that fewer than 10% of adverse events actually makes it into the system.

However, the article points out that since the dangers associated with heparin have been recognized, deaths and injuries have gone down. Varenicline is a different story:

Varenicline remains an ongoing problem, however, according to institute officials. Since the drug -- sold in the United States by Pfizer Inc. under the brand name Chantix -- was approved in 2006, it has been linked to 3,325 serious injuries and 112 deaths.

Some reports were linked to people attempting suicide or causing injury to themselves after using the drug, which can evoke serious psychiatric problems. Others were linked to blackouts, seizures or loss of consciousness, perhaps tied to sudden disturbances in heart rhythm...

...One possible explanation for the link might have been the success of the drug and the large number of people using it, the report said. But investigation showed that, during the quarter, varenicline accounted for more reports of serious injury than the top 10 best-selling prescription drugs combined.

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Posted In: Medications , Product Safety

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The Centers for Disease Control and Prevention have declared that the damaging and costly salmonella outbreak, which started in April and resulted in 1,442 reported illnesses across the country, is now over.

From the article:

Robert Tauxe, deputy director of the Division of Foodborne, Bacterial and Mycotic Diseases at the Centers for Disease Control and Prevention, said Aug. 28 that the number of illnesses being reported has dropped to a level that public health officials would expect to see in the absence of an outbreak.

Tauxe said that clusters of illnesses, created when multiple people fell ill after eating at the same restaurants, have not occurred since early July.

This is reassuring news.

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Officials with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) say that the all types of fresh tomato associated with the recent salmonella warnings are now safe to eat.

From the article:

The FDA had been gradually clearing tomato-growing regions in the United States and Mexico since it issued the warning June 7. As the weeks passed, however, growers argued the warning was becoming moot because it was no longer possible for areas that were harvesting in April to still be producing tomatoes.

Criticism of the tomato warning intensified as people continued to get sick. Investigators began looking at other potential suspects and turned their attention to cilantro and jalapeño and serrano peppers.

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Federal officials have identified the contaminant that was found in the blood-thinning medication heparin in 11 countries.

Chinese officials have denied that this contaminant has caused any deaths. As for U.S. officials, here is what one of them says:

Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, said that German regulators uncovered a cluster of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had conceded that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.

“Heparin should not be contaminated, regardless of whether or not that contamination caused acute adverse events,” Dr. Woodcock said. “We are fairly confident based on the biological information that we have had that this contaminant is capable of triggering these adverse reactions.”

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Earlier this month, the anticoagulant (blood-thinning) drug heparin was linked to 19 deaths in the U.S.A. as well as several hundred allergic reactions. A contaminant was thought to be the cause of these deaths, and now the Food and Drug Administration has said they have identified the contaminant:

The contaminant, the regulators said, is a chemically altered form of chondroitin sulfate, a dietary supplement made from animal cartilage that is widely used to treat joint pain. The agency’s announcement followed a report Wednesday in The New York Times that was the first publicly to identify the modified substance as the likely contaminant.

Disturbingly, in that same article, the regulators implied that they believe the contaminant was intentionally mixed with the heparin.

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Those who drink a can of diet soda a day are 34% more likely to develop metabolic syndrome than those who don't.

"Metabolic syndrome" is a cluster of symptoms that are risk factors for heart disease.

The reason for this link is still unknown: it might be chemical or it might have something to do with other behaviors that are, for whatever reason, common to diet soda drinkers.

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Botox is a neurotoxin used to relax muscles. People take it to relieve pain as well as for cosmetic purposes.

However, the consumer advocacy group Public Citizen is arguing that it should come with a much stronger warning label because of 16 deaths and many serious injuries that the drug has been associated with.

For more information:

Botox, also known as Botulinum toxin type A

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A new study, presented to the American Heart Association’s Scientific Sessions, has found that consumption of energy drinks is linked to heart disease and high blood pressure. The linked article contains a description of the study.

These results are unsurprising because most energy drinks contain caffeine. Any problems associated with coffee, particularly excessive coffee drinking habits, are therefore likely to show up with energy drinks as well.

Particularly risky activities include taking the energy drink before or during exercise, or in conjunction with alcohol.

Useful resources:

Brown University’s advisory page on energy drinks

ScienceDaily article on the subject

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ConAgra, the world's largest popcorn supplier, has announced on Tuesday September 4th that it will stop using diacetyl--a synthetic butter flavoring.

Diacetyl has been linked to lung disease in workers, who developed severe symptoms (extreme wheezing, for example) after inhaling the vapors of this synthetic butter while on the job. The disease is known as bronchiolitis obliterans and can cause death or leave patients with no hope but lung transplants.

In dropping diacetyl, ConAgra---which produces the popular Act II and Orville Redenbacher brands of popcorn--is following in the footsteps of Pop Weaver, another large popcorn supplier, which pulled diacetyl one month previously.

For more information on diacetyl and its effects, see the following links:

Preventing Lung Disease in Workers Who Use or Make Flavorings (National Institute for Occupational Safety and Health)

Bronchiolitis Obliterans: The Disease Explained

Food Navigator

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