JustCare

Tag: FDA

  • FDA hides data on medical device malfunctions and injuries

    FDA hides data on medical device malfunctions and injuries

    Before you let a doctor insert a medical device into you or someone you love, talk to the doctor about its safety. Kaiser Health News reports that scores of medical devices in frequent use may cause serious harm. And, the FDA hides a lot of the data on device malfunctions and injuries, even when they are serious.

    Medical devices can be anything that a doctor uses in surgery, including surgical staplers, artificial hips, surgical mesh, balloon pumps and mechanical breathing machines. Often, the FDA approves new devices without requiring the device to go through clinical trials. Malfunctions are supposed to be reported into a public database.

    However, Kaiser Health News reports that the FDA keeps two databases for these reports, one of which is hidden from public view. It’s called the “Alternative Summary Reporting Program.” Even your doctor cannot see it. As a result, your doctor cannot rely on the FDA for information on reported medical device malfunctions and injuries.

    Few people had been aware that there are two FDA databases. Experts whose profession it is to educate others about defective medical devices are unaware of the program. Apparently, the alternate confidential database has been in place since 2000. It allegedly was aimed at reducing paperwork say FDA officials who were around when it was put in place.

    The FDA began allowing medical device companies to request exemptions from public reporting without any public notice or regulations. And the FDA has clearly given a lot of medical device companies exemptions. Over the last two years, the FDA has kept 1.1 million incident reports secret.

    Device malfunctions can lead to serious injuries. In 2017, 480,000 injuries or malfunctions were reported secretly. About 100 medical devices have caused serious injuries. It appears that the FDA is doing little if anything to oversee the safety and efficacy of medical devices.

    For example, Medtronic’s surgical staplers malfunctioned almost 10,000 times in 2016 alone, but only 84 injuries have been reported publicly, some of them extremely serious. Since 2001, more than 250 deaths have been reported.  The surgical staplers cut and close tissues, so when they fail at closing a blood vessel, a patient can bleed to death.

    The question remains as to why these critical potentially life-saving reports remain secret. Who has access to them? And, what can be done to make them public immediately?

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  • Pharmaceutical companies use scare tactics to mislead public about generics

    Pharmaceutical companies use scare tactics to mislead public about generics

    Americans are always being sold, and health care products are no exception. It’s one thing when corporations are pushing the latest snack food or toothbrush, it’s another when they are pushing to make money in ways that endanger our health and well-being. The Washington Post reports that pharmaceutical companies have been using scare tactics to mislead the public about generic drugs and to keep lower-cost drugs off the market.

    We all know that pharmaceutical companies use all the tools in their arsenal to profit off of our health. They charge Americans prices that are double what they charge in other wealthy countries, which regulate drug prices. They pay Pharmacy Benefit Managers to put their higher-cost drugs on insurance company formularies and keep generics off. They pay researchers to help ensure papers are published promoting their latest drugs. They pay TV stations to promote their drugs. They pay disease organizations to support their high prices. They contribute to election campaigns of federal and state policymakers to protect against legislation that would eat into their profits. And, the list goes on.

    Now, they are said to be doing what they can to keep generic versions of their high-cost biologic drugs–biosimilars–off the market. They are misleading people. These generic biosimilar drugs are as safe and effective as the brand-name biologics. They are made with the same ingredients.

    Biologics are made with living cells. And, they can treat a range of life-threatening diseases, including cancer. But, they tend to be extremely costly, often costing many thousands of dollars.  Indeed, the majority of growth in prescription drug costs between 2010 and 2015 can be attributed  to biologics, including Humira.

    If the pharmaceutical companies succeed, it could keep these generics off the market, and many people will be forced to go without necessary treatment. They cannot afford the cost of the biologics; biosimilars could cost as little as half as much. Not surprisingly, drug spending is estimated to be between $54 billion and $200 billion higher over 10 years, if the biosimilars are not available.

    But, what’s curious is that it is the doctors who prescribe these drugs. And, they are perfectly well positioned to tell their patients that biosimilars are as safe and effective as biologics. The Washington Post article does not explain why doctors are not prepared to do so.

    FDA Commissioner Gottlieb suggested that the FDA could step in and issue warning letters to pharmaceutical companies if they are deliberately misleading people. But, it’s hard to imagine that will be helpful.

    Here’s more from Just Care:

  • FDA permits doctors to implant untested medical devices at extreme risk to patients

    FDA permits doctors to implant untested medical devices at extreme risk to patients

    In an op-ed for the Washington Post, Jeanne Lenzer and Shannon Brownlee describe how the FDA permits doctors to implant untested medical devices at extreme risk to patients. Today, 32 million people have one of these devices implanted in them.

    They report that many patients with implantable devices are at risk. They describe, for example, the implantation of a pain-relieving device in the top of patients’ spines that can cause respiratory distress and even death. The FDA approved it in 2003 even though it had never been tested on people. Likewise, artificial hips have been found to cause cobalt poisoning, harming the heart and brain and defibrillators can provide too great a shock to patients.

    Many medical devices have caused harm to patients in the last ten years–1.7 million injuries and more than 80,000 deaths.  And, many hundreds of thousands of people have medical devices implanted in them that have been recalled. But, often these devices cannot be taken out or can only be taken out at severe risk to patients.

    A lot of the blame for these faulty medical devices can be attributed to the FDA’s lax approval process. Acknowledging its responsibility, back in November, the FDA had said it would make changes to the way it approved the vast majority of devices. But, it still is not insisting on testing of these devices in people. Only a small fraction of highly risky heart devices go through stringent clinical trials.

    The issue stems from an old FDA policy to grandfather in for approval all new devices that have “substantial equivalence” to a device that was approved before 1976. As a result, about 80 percent of new devices are approved without testing. If it’s a simple device like a cane or stretcher, automatic approval makes sense. If it’s a highly complex device, such as artificial joints or a pacemaker, it is dangerous.

    Even new surgical mesh implants can be dangerous. Researchers at the University of Oxford determined that about one in eight surgical meshes sold in the US between 2013 and 2015 were like surgical meshes that had been recalled because of the harm they caused. The FDA reports that it does not look at the earlier approved device when approving the new device. And, it is doing nothing to fix this issue.

    A second way medical device manufacturers can avoid clinical trials for new devices is if they tell the FDA that they are updating a device in small ways, a pre-market “supplement pathway.” According to Harvard research, the FDA allowed virtually all “updated” pacemakers and defibrillators to be sold without clinical trials between 1979 and 2012. No surprise, one defibrillator ended up putting people’s hearts into a lethal rhythm. At the time, 250,000 people had the device implanted in them.

    The FDA has done nothing to address the flawed process. As a result of a federal law passed several years ago, MDUFA, the FDA now takes money from the medical device industry to cover its costs. And, it sees the manufacturers as its customers. The FDA head, Scott Gottlieb, supports the FDA’s inaction to correct the medical device approval process saying that “the FDA’s caution is hazardous to our health.”

    What should be done? All new high-risk implanted medical devices should go through clinical trials before the FDA approves them as safe and effective. There should also be a medical device registry that records patient outcomes. And, the FDA should operate with no conflicts of interest. It should not take money from the device manufacturers as the law currently requires, and the head of FDA should have no financial conflicts of interest.

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  • If Merck knew that Fosamax causes bone fractures and kept silent, shouldn’t it be liable?

    If Merck knew that Fosamax causes bone fractures and kept silent, shouldn’t it be liable?

    How would you feel if you were harmed by a medicine you took as prescribed and then learned that the drug company wasn’t liable — even though it knew about the risk and didn’t tell you or your doctor?

    This is exactly what has happened in the case of Fosamax (alendronate), a drug used to treat bone-thinning osteoporosis and osteopenia. After it was approved by the Food and Drug Administration and women across the country began taking the drug, the FDA and its maker, Merck, started receiving reports about spontaneous fractures of the thigh bone among women taking the drug.

    These fractures, dubbed “Fosamax fractures,” happen with no warning and usually require surgery. Although they are a rare side effect of the drug, millions of women have taken the drug. While the true number of Fosamax fractures isn’t known, about 500 women have sued Merck for failing to warn them about the risk of this painful and possibly debilitating side effect. These lawsuits are at the heart of a case, Merck, Sharp & Dohme Corp. v. Doris Albrecht, et al., that will be argued before the U.S. Supreme Court on Jan. 7, 2019.

    MedShadow Foundation, the nonprofit organization I founded in 2012 to inform the public about the side effects of medicines, along with three former FDA officials, filed an amicus curiae brief in support of Albrecht, the defendant in the case. Such “friend of the court” briefs are filed by individuals or organizations that aren’t parties in a case.

    Merck Admits Fosamax Caused The Fractures

    Merck acknowledges that Fosamax caused these fractures and that the company knew about them. In 2008, Merck started the process to get the FDA’s permission to put a warning on the drug label — the inserts that come with all medicines, providing information such as instructions on how to take a drug, what it can be used for, and warnings. The FDA reviews and must approve any information on drug labels for accuracy. These labels are generally considered fair warning to users about possible side effects or adverse events and, in that way, provides legal protection for drug companies from being sued for causing them.

    The FDA relies on manufacturers to update and make changes to drug labels throughout the lives of their drugs. That’s because approvals for new drugs are often based on small clinical trials of 1,000 or fewer people that normally last less than a year. Unusual or rare side effects and can’t be detected in such small, short-term trials. Once a drug is approved and thousands or millions of people are taking it, new side effects and adverse events can emerge.

    The spontaneous fractures caused by Fosamax didn’t begin appearing until the drug had been on the market for five years. And these fractures aren’t the only significant bone problems linked to the drug. Cases of osteonecrosis (literally “bone death”) of the jaw, a painful condition where jaw bones become exposed, were reported by people taking Fosamax. In 2013, Merck agreed to pay $27.7 million to settle 1,140 lawsuits from individuals who alleged that Fosamax caused them to develop this condition.

    Pharmaceutical companies have the best access to reports of adverse events, and they pay attention to updating drug labels as an important patient-protection safeguard.

    When Merck applied to the FDA for a label change to reflect these fractures, the FDA rejected its request. Why? Because Merck described them as stress fractures, which are minor and quite different from far more serious spontaneous fractures. A stress fracture is an incomplete bone break that is generally treated by rest and inactivity. A spontaneous fracture is a complete break that occurs in a seemingly normal bone without any trauma and must often be repaired with surgery.

    Although drug companies are responsible for updating labels, the FDA can require updates. In 2010, the FDA convened a panel to review the increasing number of reports of Fosamax-related spontaneous fractures. After reviewing the research, the panel found a clear connection between Fosamax and spontaneous thigh bone fractures. The FDA then ordered Merck to change the label.

    Women Suing Merck Claim Drugmaker Failed to Warn Them

    The women suing Merck claim that the company failed to warn them about a known adverse event. Merck is claiming that the FDA did not allow the company to change the label, making it impossible for Merck to warn women or their doctors.

    If Merck prevails, the disingenuous tactic it used for Fosamax could be replicated by other pharmaceutical companies and have far-reaching effects.

    Suppose a pharmaceutical company discovers that one of its drugs causes a serious adverse event. The company files an application for a change to the drug label, but knowingly designs the change so the FDA won’t accept it — either by minimizing the risk of the adverse event or by not accurately reflecting the risk. The drug company could then claim it isn’t liable for not warning consumers about that adverse event because the FDA denied the label change.

    If the Supreme Court allows drug companies to circumvent the law this way — which is what Merck is attempting to do in this case — it would remove the motivation for pharmaceutical companies to provide the FDA with timely and transparent information.

    MedShadow Foundation is a small nonprofit with limited resources. Yet we have taken on the costly and time-consuming process of filing an amicus brief because we believe that pharmaceutical companies cannot be allowed to obscure the risks, side effects, and adverse events of drugs — or exaggerate their benefits.

    The foundation’s mission is to protect quality of life by ensuring that people have all the known information about side effects before deciding to take a prescription or over-the-counter drug. Today, pharmaceutical companies are motivated to reveal previously unknown risks and warn the medical community so they can’t be sued for damages. The FDA and the law must maintain that obligation to protect people from unnecessary harm.

    There will always be some risk with medicines, but consumers have the right to all the information about benefits and risks of drugs — whenever that information is discovered — so they can make informed decisions about their health and well-being.

    This article originally appeared on Stat and is also on Medshadow.org.

    Here’s more from Just Care:

  • Avoid memory supplements

    Avoid memory supplements

    Today, there are about 80,000 dietary supplement products on the market, up from 4,000 25 years ago. Of those, some 500 are memory supplement products. The US Government Accountability Office (GAO) tested three of the most popular memory supplement products to determine whether they contained the ingredients listed on their labels. It found that two of the three did not and warns that they could be dangerous for older adults. Avoid memory supplements as they might contain unsafe ingredients.

    For two of the three memory supplement products the GAO tested, the GAO found they did not contain Ginkgo biloba, even though it was listed as an ingredient on their labels, or the product contained far less than its label indicated. Rather, both memory supplement products contained an unknown substitute, and the GAO could not therefore vouch for the products’ safety. The third memory supplement product tested contained the fish oil and other ingredients listed on its label.

    The GAO warns that heavy-metal contaminants in supplements, such as arsenic, cadmium, chromium, lead and mercury, can be dangerous to people’s health. They may cause cancer. Indeed there are many ingredients in supplements that can cause harm.

    Notwithstanding the fact that supplements are largely unregulated, and they may contain ingredients that are dangerous to people’s health, supplements are a multi-billion dollar industry. Memory supplements, which are a tiny share of the supplement market, generated $643 million in sales in 2015.

    Curiously, the government claims that it does not allow importation of prescription drugs because they may be unsafe, yet it allows the unfettered sale of supplements, which are likely to be more unsafe than drugs bought from verified pharmacies abroad.  Moreover, though the FDA has authority to regulate dietary supplements, generally the FDA tends not to do so and, when it does, it is only after they go to market. The FTC has authority to regulate advertising of supplements but does precious little in that regard to ensure truth in advertising.

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  • Amarin makes unsupported claims about its heart disease medicine

    Amarin makes unsupported claims about its heart disease medicine

    As we all know, some pharmaceutical companies will go very far to sell their products. Shefali Luthra reports for Kaiser Health News that Amarin has been making unsupported claims about the benefits of its medicine, Vascepa. Don’t believe their fishy marketing.

    Amarin’s medicine is simply purified fish oil. And, Amarin is claiming that it can work miracles for people with cardiovascular (heart) disease. The problem is that the evidence it just released to support its claims is questionable at best. Cardiologists who reviewed its study say that the placebo–mineral oil–to which Vascepa was compared, may have caused blood test changes, according to Forbes. So, comparing Amarin to the placebo, which may have caused heart problems or strokes, may be inappropriate. Put differently, Amarin’s use of a placebo that was not inert in its clinical trials could have made Vascepa, by comparison, appear to have clinical benefits it does not in fact have.

    Amarin’s stock price is up for the moment. But, its advertising and promotion of its questionable claims about Vascepa’s clinical benefits may be leading to unwarranted increases in sales of its medicine. Some doctors will be more likely to prescribe it to people who may not benefit at all from it.

    It is concerning that Amarin is able to market and advertise its drug as helping with heart disease without strong supporting evidence and FDA approval. To date, the FDA only has approved Vascepa to address high triglyceride levels, which can cause pancreatic issues.

    Without a good clinical trial with an inert placebo, Amarin’s claims about Vascepa are likely to be inaccurate; its clinical benefits may be no better than standard fish oil supplements, which may have little if any benefits.

    Supplements can be harmful for a number of reasons, including that they are not overseen by the FDA and can contain ingredients that can be dangerous to your health. Amarin is trying to suggest that because its fish oil product is FDA-approved it is safer. But, it is difficult to know for several years whether a drug is safe or who if anyone it helps. In this case, there is no evidence to suggest Vascepa is any better than fish oil supplements.

    Vascepa costs $280 a month today, up more than 40 percent in five years.

    Here’s more from Just Care:

  • How to ensure the drugs you take are safe and effective

    How to ensure the drugs you take are safe and effective

    Drugs recently approved by the Food and Drug Administration–within the last ten years–may turn out not to be safe or effective. How can this be? And, how can you ensure the drugs you take are safe and effective?

    To be clear, the FDA only approves drugs that it finds to be safe and effective.  But, it bases its approval on limited data. So, what might appear to be safe and effective at the drug approval stage, may turn out not to be. One in seven older adults experience harmful drug side effects.

    To get a drug approved, pharmaceutical companies must conduct clinical trials or lab tests that show the drug is safe and works better than a placebo, essentially a sugar pill or nothing. But, clinical trials are usually performed on a small cohort of people, a tiny fraction of the number of people who will end up taking the drug. Often the people in the clinical trials are not elderly or children or otherwise like the people who are prescribed the drug. As a result, in the real world, outside of the clinical trials setting, the drug may be ineffective or, worse still, dangerous for some people who take it. Drug safety is a big issue.

    Sometimes, a drug’s potentially dangerous side effects may only become evident after six months or a year of a person taking it. But, a clinical trial may last for only six months. And, about 10 percent of the time, a drug may be prescribed for off-label use. When prescribed off-label, for a different condition from which it was tested, people may experience dangerous side effects. Keep in mind, as well, that peer-reviewed papers showing the value of the drug for a particular condition, may be biased. Too often the papers’ authors have financial ties to the drug industry.

    Unfortunately, the FDA does not do the job it needs to do monitoring drugs after they are approved and publicly reporting their side effects. Indeed, because it is very hard to prove that people’s side effects stem from a particular drug, drugs with dangerous side effects may not be pulled from the market for many years. Even warnings about these side effects may not be published.

    What can you do? 

    1.  Choose your doctors carefully. Make sure that your doctors listen to you and take the time to know you.
    2. At each doctor’s visit, question whether you still need to be taking the prescription drugs your doctor has prescribed or whether it is possible to stop taking one or more of them.
    3. Check to see whether your doctor is taking money from drug companies on Dollars for Docs. If so, consider talking to your doctor about that in connection with the drugs your doctor has prescribed for you.
    4. If there’s a generic substitute for the drugs you take or a lower-cost alternative, ask your about switching to that drug.
    5. If a drug you are taking was recently approved by the FDA, ask about side effects and whether there is an older drug you could be taking instead. With an older drug, you have a better sense of the drug’s safety and usually pay less for it.

    Ironically, the FDA does not allow people to import drugs for personal use for “safety” reasons. That said, Kaiser Health News reports that 19 million Americans import drugs from abroad every year. No one has ever reported a safety issue from prescribed drugs bought from a verified pharmacy abroad. Indeed, by some counts 70 percent of the drugs we take in the US were manufactured abroad.

    Here’s more from Just Care:

  • Should generic drug labels include off-label uses?

    Should generic drug labels include off-label uses?

    A new bipartisan Senate bill would allow generic drug labels to include off-label uses, Nicholas Florko reports for StatNews. With an FDA finding of sufficient evidence, the bill empowers generic drugmakers to market drugs for particular conditions even though those drugs have not been scientifically proven to treat those particular conditions. It is hard to believe this helps anyone other than the drugmakers.

    Senators Orrin Hatch (R-UT) and Michael Bennett (D-CO) introduced the legislation that would lift marketing restrictions on generic pharmaceutical companies. Today, generic drug companies need approval from the FDA to change a drug’s label. Only then can they market a drug as a treatment for a new condition or a new drug dose. And, that takes time and money.

    Generic drug companies also do not have the right to set in place the process for marketing a drug for off-label use–a different treatment or a different dosage from what was originally intended. Brand-name drug companies only have that right. But, if the brand-name product is pulled from the market, the brand-name drug company that had promoted the drug for a particular use has no incentive to promote the drug for another use. So, the drug labels rarely change.

    The Hatch-Bennett bill would give the FDA authority to review data on generic drugs for off-label use when there is no brand-name competitor. If the FDA finds that there is enough evidence for it to be sold for those uses, the FDA can require a label change. But, the bill is silent as to what evidence would constitute sufficient evidence to require a label change on the generic drug.

    This bill appears to give a lot of power to the FDA and the generic drug makers without adequately protecting individuals. No clinical trials showing the clinical benefits of the off-label use of the drug are required to determine safety issues.  And, doctors can already prescribe drugs for whatever use they please. A label change is not required for doctors to prescribe a drug for off-label use.

    The label change simply expands the drug companies’ ability to market a drug for a new use. Who is really benefiting here?

    Here’s more from Just Care:

  • Public believes Trump’s drug plan will not lower drug prices

    Public believes Trump’s drug plan will not lower drug prices

    The public wants the federal government to address prescription drug prices. President Trump has said that it is one of his “greatest priorities” and has released a plan to do so. But, Trump’s plan will more likely lead to higher drug prices since it does nothing to keep pharmaceutical companies from charging high prices. And, the public is not fooled. A new Politico-Harvard poll shows that most Americans believe Trump’s plan will not lower drug prices.

    The majority of Americans (58 percent) do not think Trump’s plan will work. Only about one in five Americans (22 percent) think Trump’s plan will bring down their drug costs.

    More than half (57%) of adults believe the President’s prescription drug plan will not make a difference. About one in eight (13%) believe they or their family will pay more.

    All in, the majority of Americans believe that three of the four key elements of Trump’s plan will not bring down drug costs.

    1. About two out of three Americans (66 percent) like the idea of having the FDA approve more generics to buoy competition. This is the one element that a majority of people (56 percent), Democrats and Republicans, believe  could bring down drug prices.
    2. The piece of Trump’s drug plan with the greatest public support (81 percent) is for permitting pharmacists to tell people whether the retail price of their drugs is lower than their copay. That said, only 42 percent of people believe it will lower drug prices.
    3. Almost two out of three Americans (63 percent) like Trump’s idea of requiring drug companies to list drug prices in their TV ads. But, again, only a small minority (28 percent) believe it will lower drug prices.
    4. Only one in four Americans (26 percent) agree with Trump that other countries should be paying more for their drugs. And, fewer than one in five Americans (19 percent) believe it will bring down drug prices.

    Moreover, the majority of Americans (54 percent) do not believe that President Trump’s plan will lead to the development of more breakthrough drugs. Only one in three people (33 percent) believe it will work to deliver more breakthrough drugs.

    Here’s more from Just Care:

  • Pharma frequently not reporting postmarketing studies

    Pharma frequently not reporting postmarketing studies

    Many recent FDA-approved drugs and biologics turn out not to be safe and effective and eventually are taken off the market or given new warning labels. To help ensure a drug’s effects are well understood after they come to market and protect patient safety, the FDA often requires pharmaceutical companies to perform post-marketing studies. A May 2018 study published in BMJ finds that Pharma frequently does not report postmarketing studies as required. Too often, the study results are a black hole.

    Indeed, the BMJ research finds that more than one out of four required studies were not published on clinicaltrials.gov. That’s correct. The results of the postmarketing studies were not publicly available in more than one out of four instances.

    Moreover, the results of clinical studies published on clinicaltrials.gov contained so little information, with an average length of 44 words, as to be unhelpful. The FDA gives pharmaceutical companies a lot of freedom to design these studies. So, the studies often do not address the issues that doctors and patients want to understand.

    Between 2009 and 2012, the FDA required pharmaceutical companies to do follow-up studies of 97 out of 110 new drugs and biologics it approved, imposing 437 post-marketing requirements, including 110 clinical trials. Many study results were not reported by their deadline. Fewer than six in ten post-marketing study results were published in peer-reviewed journals.

    The researchers concluded: “These findings highlight the need for more detailed postmarketing requirement study descriptions, increased FDA transparency, and clearer and more consistent registration and results reporting standards for these critical FDA required studies.”

    Here’s more from Just Care: