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Tag: FDA

  • Advil and Aleve increase risk of stroke and heart attack

    Advil and Aleve increase risk of stroke and heart attack

    According to the FDA, use of NSAIDs, (nonsteroidal anti-inflammatory drugs,) such as Advil (Ibuprofen) and Aleve (Naproxen), increase your risk of stroke and heart attack. As a result, the FDA now requires drug labels for all prescription NSAIDs to warn people of this risk. Over-the-counter non-aspirin NSAIDs also must contain this information.

    People have been using NSAIDs since 1999 to treat pain and fever stemming from, among other things, colds, flu, arthritis and headaches. They offer less risk of gastrointestinal bleeding and other problems associated with other pain medications. But, over time, the FDA has seen greater risk from these drugs.

    How much Advil and other NSAIDs is too much, you ask? Read the label on the bottle, and talk to your doctor. Here’s more information from MedlinePlus, a resource of the U.S. Information Library of Medicine.

    The new FDA warning says:

    • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
    • The risk appears greater at higher doses.
    • It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
    • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
    • In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
    • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
    • There is an increased risk of heart failure with NSAID use.

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  • What does a Trump FDA look like?

    What does a Trump FDA look like?

    There are many reasons to be concerned about food and drug safety today. Even with an FDA committed to ensuring our food and drugs are safe and effective, the FDA allows chemicals in our foods that may not be safe and approves prescription drugs for use that have been pulled from the market because they are later found to be unsafe. So what does a Trump FDA look like?

    If you believe that the FDA provides a critical function in keeping drugs from going to market until they are shown to be safe and effective, you should be concerned about the FDA’s future. President-elect Trump is considering Jim O’Neill to head the agency, and StatNews reports that O’Neill has made clear that he thinks people should be free to test any drugs they’d like at their own risk. Specifically, O’Neill has proposed that the FDA should not have to establish that a drug works to treat a condition before it approves it, only that it is safe.

    While in theory, failing to focus on drug efficacy might sound like a great way to get more drugs to market faster, it risks undercutting our ability to understand the value of particular drugs for particular conditions. Instead of a Consumer Reports-type rating based on scientific evidence, we’ll have customer reviews. But, customer reviews can be manipulated by companies wanting to push a product. And, even when customer reviews are genuine, they may be extremely misleading when it comes to whether a drug works. People’s ability to rate the efficacy of a particular drug is far different from their ability to rate hotels and vacuum cleaners.

    O’Neill is a libertarian and billionaire Peter Thiel’s managing director at Mithril Capital Management. He has neither a medical background nor a science background, as you would expect an FDA chief would have. However, O’Neill did work in the U.S. Department of Health and Human Services in 2002, during the George W. Bush administration.

    Scott Gottlieb is another person under consideration for the FDA chief post. Scott Walker enlisted Gottlieb as a senior adviser to his presidential campaign.

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  • Taking supplements? You’re at risk for liver damage

    Taking supplements? You’re at risk for liver damage

    There’s plenty of data to suggest that taking vitamin or herbal supplements offers little value if you are otherwise healthy. It’s much better to eat a healthy diet and exercise; it also saves you money. Now, new findings published in Hepatology indicate that if you’re taking supplements, you’re at risk for liver damage.

    Your liver serves to make sure that your body benefits from the nutrients in the food you eat and gets rid of harmful substances in your blood. But, certain herbal, body-building, and weight-loss supplements have been found to harm the liver in ways that prevent it from doing its job. Other supplements marketed for depression, sexual performance and to treat digestive issues were also found to harm the liver.

    Supplements studied were found to cause about one in five of all liver injuries. Although the researchers could not determine which particular ingredients in the supplements caused liver damage, they found that anabolic steroids found in body-building supplements, green tea extract and agents in multi-ingredient nutritional supplements were likely culprits.

    The Food and Drug Administration, FDA, does not regulate supplements or oversee their safety in any way.  Just last week, GNC, the world’s largest retailer of dietary supplements entered into an agreement with the U.S. Department of Justice to change its use of certain dietary ingredients and supplements. It also paid the federal government a $2.25 million fine. GNC was selling supplements with synthetic stimulants and claiming they were natural plant extracts.

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  • Low-cost hearing aids coming to pharmacies

    Low-cost hearing aids coming to pharmacies

    There’s some good news for people struggling to afford hearing aids. The Food and Drug Administration has issued a guidance document that permits the sale of hearing aids without a prescription. Experts predict that, soon, buying low-cost hearing aids at the pharmacy over the counter should become the norm, much like buying reading glasses.

    Today, 30 million people in the U.S., mostly older adults, experience hearing loss. Hearing aids typically cost close to $5,000 a pair, $2,300 apiece on average, according to the White House blog. And, because Medicare does not cover hearing aids, most people have to pay the full cost of hearing aids if they want them.

    Fortunately, Medicaid covers hearing aids in 34 states and territories, according to the Kaiser Family Foundation. Unfortunately, more than 80 percent of people who would benefit from hearing aids today do not have them because of their cost and the cost of getting a medical evaluation.

    As a result of the FDA’s new guidance, you will no longer need to get examined before you can get a hearing aid. While the FDA regulation that people get a medical evaluation or sign a waiver in order to get a hearing aid remains in place, the FDA has said that it will not enforce the requirement.

    Once hearing aids can be bought without a prescription, many new manufacturers should surface and the price of hearing aids should come down significantly. Today, there is very little competition in the marketplace. Only six companies–one U.S. and five foreign–sell hearing aids in the United States.

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  • Cures Act threatens drug safety and efficacy

    Cures Act threatens drug safety and efficacy

    After an intense lobbying campaign heavily funded by the pharmaceutical industry and featuring sick children and pleading parents, a bill called the 21st Century Cures Act (“Cures Act”) easily passed through both houses of Congress this month, and the President is expected to sign it into law. Everyone wants cancer and other dire diseases cured, but will this 996-page bill, largely fashioned by politicians and their corporate allies really work towards those ends? Many consumer advocacy groups, such as the National Center for Health Research and Public Citizen, as well as some doctors in universities who don’t take funding from drug companies, believe that the legislation will do more harm than good.

    The bait that hooked the vote of many of those in Congress is the increased funding for cancer and other research at the National Institutes of Health, although Congress still may not appropriate this funding each year. Members of Congress also liked the idea that the bill would streamline the FDA approval process for prescription drugs and medical devices. But, our FDA approves these products faster than its counterparts in other part of the world and approves almost 90% of products put forward. And, it does so already increasingly and worryingly under lower standards than in the past. Many drugs are approved that turn out not to work at all. These drug often stay on the market nonetheless.

    As a result, we all pay higher drug and health costs.

    The 21st Century Cures Act would actually set some standards at the FDA back to the 20th century, as less reliable evidence would be accepted, such as anecdotes or patient experience, and observational studies, notoriously less trustworthy than randomized, controlled clinical trials.

    While more than 200 patient groups supported the Cures Act, most of these groups receive a substantial portion of their support from the pharmaceutical companies that stand to benefit most from the bill.

    As StatNews reported, most of the 1,300 (!) lobbyists pushing for the Cures Act worked for the pharmaceutical industry. Not surprisingly, the primary congressional sponsors of the bill, Representatives Fred Upton (R-Mich), and Diana DeGette (D-Colo) received some of the largest donations from pharmaceutical companies among members of Congress.

    Although the increase in funding for the National Institutes of Health hardly needed to be linked to the provisions of the bill likely to harm public health, there are other provisions that may be beneficial. Some funding will be allocated to help states fight the opioid drug epidemic, ironically created in large part by marketing campaigns by the drug industry. A rider to the bill also boosts funding for mental health care.

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  • Should companies market drugs “off-label”?

    Should companies market drugs “off-label”?

    Earlier this month, the Food and Drug Administration (FDA) held an important public hearing on “off-label” marketing of drugs and medical devices to physicians. When medical products are prescribed “off-label,” the FDA has not approved them as safe and effective for the treatments for which they are being used. To date, “off-label” marketing has been illegal, as it violates the very basis of why we have an FDA.

    Over the past few years, corporations have been claiming in lawsuits that the restrictions on “off-label” marketing violate their free speech, and they have been making some headway against the FDA. On November 9 and 10, FDA officials heard from both corporate advocates as well as consumer group advocates and people who have been harmed by off-label use of drugs and devices.

    Doctors often prescribe drugs for uses that the FDA have not been officially approved; they are free to practice medicine as they see fit. But, often experts argue that 80% of off-label prescribing is “not based on strong medical evidence.”

    Sometimes off-label prescribing is well-justified. For example, many drugs are not tested in children or in people with rare diseases and may not be approved for them. As a result, doctors who treat these patients often must use drugs off-label. Drug and device companies also often don’t do the testing for additional uses because it is not worth the cost to them. After patent protection expires on their medical products, they don’t expect to make much money off of them.

    Doctors have many ways of learning about drugs and other treatments, besides directly from industry sales representatives and ads. They may read journal articles and clinical practice guidelines or gain knowledge from disease advocacy groups and professional organizations.

    Corporations say they should be able to advertise with any information that is truthful and not misleading. And there’s the rub. Who decides the truth? Who decides whether the evidence presented really does mean a drug or device is helpful and the risks it entails are worth it?

    Unfortunately, one can’t depend on evidence from peer-viewed journals. Time and time again, even randomized controlled trial evidence that gets published has been shown to be inaccurate. Companies use inappropriate statistical methods in analyses, for example, or leave out data or participants they shouldn’t have.

    Clinical practice guidelines are often no better and are another way pharmaceutical corporations, with their rich coffers, incent doctors to prescribe medical products that may not be safe or effective, according to Dr. John Ioannidis , who established a center at Stanford to study bias in research, and many others.

    Drug companies spend around $27 billion annually on marketing. Fines of even billions of dollars for violations of the off-label marketing laws are written off as “the cost of doing business.”

    The FDA continues to collect input on the issue and hopes to update guidelines on the issue next year that will be fair to both manufacturers and to consumers.

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  • More than four in ten clinical trial results are not available for review

    More than four in ten clinical trial results are not available for review

    To shed more light on safe and effective drug treatments, the U.S. Department of Health and Human Services, HHS issued a final rule requiring all institutions performing clinical trials to post a summary of their trial results on clinicaltrials.gov.  However, according StatNews, the University of Oxford Evidence-Based Medicine Data Lab has found that more than four in ten trial results are not available for review. Sanofi, Novartis, The National Cancer Institute, the Mayo Clinic and GlaxoSmithKline are five of the worst offenders.

    Until all trial results are posted on clinicaltrials.gov. we cannot fully understand the advantages and harmful effects of different treatments. Of particular concern is that trials with negative results are less likely to be posted on clinicaltrials.gov than those with positive results. It should lead us to wonder about whether the drugs whether the drugs we’re taking are safe, and if they are safe, do they work? Once popular drugs are not infrequently pulled from the market.

    The Oxford data lab has compiled a list of all the universities, government agencies and pharmaceutical companies that have not posted all their trial results on clinicaltrials.gov. The list is available online, ranking companies based on the number of trial results not reported in order to pressure these companies to comply with the law and post their results.

    In total, over the last decade, these entities have registered 25,927 clinical trials. But, they have not posted results for 45.2 percent of them, 11,714 clinical trial results.

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  • Vast majority of Americans support government drug price negotiation

    Vast majority of Americans support government drug price negotiation

    A September 2016 Kaiser Family Foundation poll reveals that a growing number of Americans say “no” to the way pharmaceutical companies are allowed to do business. They find drug prices unreasonable, 77 percent, up five points from just a year ago. They want the government to keep the pharmaceutical industry in check. The vast majority of Americans support government drug price negotiation for people with Medicare. And, even more Americans want  pharmaceutical companies to publicly report how they set prices. 

    More than eight out of ten Americans (82 percent) support government drug price negotiation, up from 79 percent in April 2015. Americans are angry about how drug companies set prices. They want to understand their rationale (84 percent want a public accounting).

    Almost eight in ten Americans (78 percent) now want the government to restrict the amount drug companies charge for expensive medications for costly conditions like hepatitis or cancer.  In the meantime, more than seven in ten (71 percent) support legal drug importantion from Canada. They may not know that while it is illegal to import drugs from abroad, the FDA has never prosecuted anyone for importing medications for personal use or that some websites help people know which international pharmacies are safe to use and help people compare drug prices.  

    Two out of three Americans (66 percent) support Secretary Clinton’s proposal to create an independent panel that oversees drug prices for prescription drugs. The majority of Americans seem to be ok with allowing drug companies to advertise their drugs to consumers. 

    Interestingly, it seems that more Americans are concerned about the future of the Affordable Care Act (66 percent) and health insurance premiums (60 percent) than the cost of prescription drugs (51 percent). They say the Presidential candidates’ positions on health insurance and health care costs are more likely to affect their vote than their positions on prescription drug prices.

    If you want Congress to rein in drug prices, please sign this petition to Congress.

    __________________________

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  • Drug companies must now disclose most clinical trial results

    Drug companies must now disclose most clinical trial results

    For years, drug and medical device companies have been able to conduct clinical trials and then, depending upon results, determine which ones to make public. They were not required to let the public know about poor outcomes of clinical trials, even for a drug receiving FDA approval based on a different clinical trial with a beneficial outcome. Now, these companies must disclose most clinical trial results, even if they show a drug or device may not be safe or effective.

    The U.S. Department of Health and Human Services has issued a final rule expanding the conditions under which pharmaceutical companies, medical device companies and manufacturers of biologics must register clinical trials and disclose summary results information on ClinicalTrials.gov, including information about harmful side effects.  The National Institutes of Health has issued a policy that complements the HHS policy for registering and disclosing summary results information on ClinicalTrials.gov for all NIH-funded trials, including trials that are not subject to the HHS final rule.

    NIH Director Francis S. Collins, M.D. said that he wanted to make sure the public got maximum value from clinical trials, whether funded with government money or private money. “Access to more information about clinical trials is good for patients, the public and science.”

    The goal of clinical trials is to ensure that health care drugs and devices are safe and effective. They sometimes also indicate when one medical treatment is better for a specific condition or particular subpopulation (e.g., children, older adults) than another.

    These new requirements should make it easier for people to learn about clinical trials in which they might be interested in participating as well as new possible treatments for their conditions. And, more information about clinical results will enable patients and doctors to make more informed decisions about appropriate treatments. It will also help researchers design studies based on more information about clinical trial results.

    The HHS final rule requires companies to register and disclose summary results for trials of most products that the FDA regulates. However, phase 1 drug and biological products and small studies to determine the feasibility of device products are excluded from the requirement. The NIH policy extends to all NIH-funded trials, including phase 1 clinical trials of FDA-regulated products and small studies to determine the feasibility of products; it also applies to products that the FDA does not regulate, including behavioral interventions.

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  • Clinton proposes plan to rein in some drug prices

    Clinton proposes plan to rein in some drug prices

    Recognizing that government intervention is needed to rein in some drug prices, Hillary Clinton has proposed a plan to help ensure people in the U.S. can afford their life-saving medications, if she’s elected president. This new plan supplements her proposals for reining in drug prices more generally, establishing a panel to oversee the price of critical drugs. The panel would be empowered to penalize drug companies that hike prices substantially on life-saving drugs that have been available at far lower prices for a long time; it could also make reasonably priced drugs available.

    While Clinton should be commended for bringing the issue of high drug prices into the spotlight of the presidential campaign, the devil is in her plan’s details. Practically, it’s hard to see how her proposal gets implemented in a way that serves the public interest. You can imagine a panel debating what it means for a drug price to increase substantially or how long a drug has to have been on the market for the panel to address its steep price. The efficacy of the oversight panel turns on who sits on it and panelists’ sense of what the right price of a drug should be.

    Clinton is proposing panelists from the public health and consumer protection worlds, but her executive authority is limited. Arguably, most of Clinton’s enforcement tools require Congressional action. Congress would need to pass legislation establishing a panel to impose penalties on drug companies that raise prices on drugs too high. And, it would have to ensure the panelists were chosen for their independence, a stretch to say the least.

    Congress has never been inclined to take action to rein in the price of drugs even though drug price negotiation is a top policy priority for Americans, so it’s hard to see why it would now. Members feign concern about prices and fail to act claiming they don’t want to stymy drug companies from innovating; PhRMA’s largesse when it comes to campaign contributions is formidable.

    Presumably, Clinton has authority to have the FDA lift its ban on importation of drugs from abroad for personal use to ensure their affordability. But, it’s unclear how much help that would be. While it is illegal to import drugs from abroad for personal use today, millions of people already do so in order to afford their medications. No one stops them. And, the FDA has never prosecuted a person for so doing.

    Also, the Bayh-Dole Act already gives the US government the executive authority to limit the price of many drugs that were developed with federal funds, though the government has never chosen to use its authority in the past 35 years under Democratic or Republican administrations. A Clinton administration arguably could choose to use its executive authority under Bayh-Dole or through a newly energized Consumer Financial Protection Bureau to ensure drug prices are reasonable.

    The question remains whether there’s steak in Clinton’s proposals or are they all sizzle?

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