Tag Archive for: FDA

7 Ways the FDA Decision to Sell Birth Control Pills Over-the-Counter Hurts Women

/in , , , , , , , /by

The Biden administration approved the first over-the-counter birth control pill — a drug associated with mental and physical harms including higher rates of breast cancer, depression, and life-threatening ectopic pregnancies.

On Thursday, Biden’s Food and Drug Administration (FDA) authorized the sale of Opill (norgestrel) without requiring a physical examination or prescription. Opill is a low-dose minipill also known as a progestin-only pill (or POP), unlike the standard birth control pill which combines estrogen and progestin (E+P).

The FDA press release trumpeting the decision listed “[t]he most common side effects of Opill” as “irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.” But the progestin-only pill contributes to significantly worse side effects which the Biden administration left unmentioned.

1. Cancer. Hormonal contraception of all kinds increases the risk of certain forms of cancer. But studies show taking the progestin-only birth control pill specifically raises the odds of breast cancer, the most common cancer among women aside from skin cancers. In March, researchers at Oxford University found “a relative increase of around 20% to 30% in breast cancer risk associated with current or recent use of either combined oral or progestin-only contraceptives.” Even Biden’s celebratory press release noted, “Opill should not be used by those who have or have ever had breast cancer.”

The threat is not restricted to breast cancer. Progestin-only birth control also raises the risk of developing cancer of the glands (adenocarcinoma) or of the skin (squamous cancer), European researchers found in 2021. The same year, the Department of Health and Human Services (HHS) listed progesterone among substances that “are known or reasonably anticipated to cause cancer in humans.”

Progestin-only minipills may also cause women to suffer from cancer longer, with greater complications, by camouflaging cancerous cells from the body’s defense systems. “[P]rogesterone helps the tumor cells go unnoticed,” said Christy Hagan, PhD, assistant professor at the Cancer Center of the University of Kansas. “If breast tumor cells circulating in our body are exposed to progesterone, the hormone may conceal the tumor’s danger signals that are normally recognized by the immune system.”

The danger rises if progestin is combined with estrogen. The standard birth control pill (E+P) is a Group 1 carcinogen. The National Cancer Institute admits that “studies have provided consistent evidence that the risks of breast and cervical cancers are increased in women who use oral contraceptives.” Standard contraceptives also increase the chance of cervical cancer, with the risk rising progressively the longer a woman takes it: 10% higher for women who took the pill less than five years, 60% increased risk after 5–9 years of use, and doubling the risk after taking the pill 10 or more years.

Women maintain a higher likelihood of developing cancer for 10 years after they stop taking birth control pills.

2. Depression. Every birth control pill makes women more likely to become clinically depressed, but the progestin-only minipill seems to have the worst impact on women’s mental health. “All forms of hormonal contraception were associated with an increased risk of developing depression, with higher risks associated with the progesterone-only forms,” concluded Dr. Monique Tello of Harvard Medical School. (Emphasis added.)

Dr. Tello found one out of every 200 women who takes hormonal contraception of any kind will develop depression. At least nine million American women aged 15-49 use birth control pills, according to the CDC. That means 45,450 U.S. women will develop depression due exclusively to their contraceptive choice.

Foreign researchers have confirmed the link between POPs and negative mental health. A Danish study found women who took the minipill were 30% more likely to be prescribed antidepressants for the first time, and teenage “users of progestin-only pills experienced a 2.2-fold higher rate” than adolescents (15-19) who never used hormonal birth control. A Swedish study found those who ingested progestin-only pills were most likely to be prescribed antidepressants, especially among teens aged 16-19.

Progestin-only pills can amplify negative conditions and incarnate emotional pain in the rest of the body. Under stress, progesterone increases levels of the stress hormone cortisol; high cortisol levels lead to greater weight gain and fat retention, diabetes, high blood pressure, and osteoporosis. Progesterone levels are “likely causal factors for the mood symptoms experienced by women with premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD),” a team of researchers from Sweden and New Zealand found in 2020.

“A recent review has shown that sex hormones have significant impact on brain areas related to emotional and cognitive functioning,” wrote two researchers at Monash University in Melbourne, Australia. “Progesterones have been shown to induce depression, particularly in vulnerable women.” How do women know if they are “vulnerable”? A physician’s appointment could screen women’s hormonal state. Yet doctors sometimes fail to inform women of potentially mood-altering side effects.

“Hormonal birth control is a lie sold to women,” wrote Chrissy Clark of the Daily Caller. “For 15 years I was on the pill & had inexplicable anxiety and depression[,] symptoms my doctors NEVER thought to tell me were the result of hormonal birth control. I’m over 1 year off hormonal birth control now. My skin is clearer, my anxiety is gone, & my depression is non-existent.”

“Ladies, you deserve freedom from these side effects. Get. Off. The. Pill.”

3. Ectopic Pregnancy. Women who get pregnant while taking progestin-only pills such as the Opill have a greater risk of experiencing a life-threatening ectopic pregnancy, in which the newly conceived child implants in one of the fallopian tubes instead of the uterus. If undetected, the fallopian tube can rupture, causing serious side effects and even death. “If you get pregnant while taking the minipill, there appears to be a slightly higher chance” of an ectopic pregnancy, notes the Mayo Clinic. WebMD puts it bluntly: “If you get pregnant while taking the minipill, it can cause problems. You’re more likely to have an ectopic pregnancy.”

4. Potential Abortifacient. While they frequently block ovulation, all forms of hormonal birth control have the potential to induce an early abortion by preventing implantation — including the Opill the Biden administration has authorized for sale over-the-counter. “Progestin-only pills don’t prevent ovulation as well as combination birth control pills. Therefore, its effectiveness is slightly lower,” according to the Cleveland Clinic. Instead, the minipill “thickens cervical mucus and thins the lining of the uterus,” notes the Mayo Clinic. “These prevent sperm from reaching the egg and a fertilized egg from implanting in the womb.”

A “fertilized egg” is a dehumanizing term for a newly conceived child.

5. Blood Clots, Heart Attacks, and Strokes. The Mayo Clinic notes that high doses of progestin “sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes,” which “can be very serious and cause death.” While low-dose progestin-only pills are not known to increase blood clots by themselves, selling the pill over-the-counter denies women a medical screening that might detect if they already have elevated levels of progestin, or other factors that put them at high-risk for serious complications.

The standard birth control pill (E+P) makes women two to 10 times as likely to develop blood clots, which can lead to such life-threatening conditions as pulmonary embolism, deep-vein thrombosis (DVT), and increased risk for stroke. The Cleveland Clinic estimates “10 in 10,000 people per year develop [blood] clots as a result of being on birth control.” That means as many as 909 of the nine million American women who take the birth control pill will suffer blood clots attributable exclusively to contraception. Dr. Lynn Keegan found 300-400 women die every year from the side effects of all forms of hormonal contraception.

Considering the wave of seemingly inexplicable hospitalizations and deaths among young people of bothsexes over the last few years, for variousreasons, Americans should be concerned OTC birth control compounds the damage of other Biden policies that benefit Big Pharma.

6. Diabetes. Links between POPs and diabetes seem to be slight and remain under review. Still, researchers in Chile discovered “progesterone accelerates the progression of diabetes” in mice. Korean researchers found progesterone increases blood glucose levels under certain circumstances in 2021, and Chinese epidemiologists found higher levels of progesterone associated with prediabetes in 2019. Specific circumstances multiply progestin’s potential blood glucose impact. “[T]he use of a progestin-only [oral contraception] during breast-feeding was associated with a nearly 3-fold increase in the incidence of diabetes” among women who had previously had gestational diabetes, Japanese researchers discovered.

7. Religious Liberty. Selling birth control over the counter is likely to become a flashpoint in the ongoing battle to preserve religious liberty from encroachments by the Biden-Harris administration. The Biden administration issued an HHS guidance last July, warning pharmacies it will impose stiff, legal “corrective action” on pharmacists who refuse to hand out the abortion pill mifepristone and instruct customers “how to take” it. Liberal politicians and global governance bodies have long argued sexual “rights” should trump religious liberty. The United Nations Population Fund (UNFPA) called on governments to actively counteract “religious” objections to so-called “emergency contraception” in its 2012 annual report, which declared, “Family planning is a human right. It must therefore be available to all who want it.” The Lancet and the Los Angeles Times have even suggested nuns should take the birth control pill to reduce their risk of certain cancers.

Religious liberty is the first liberty enshrined in the Constitution. Religious rights are human rights. And since most church-goers are women, it’s fair to say, “Religious rights are women’s rights.”

AUTHOR

Ben Johnson

Ben Johnson is senior reporter and editor at The Washington Stand.

EDITORS NOTE: This Washington Stand column is republished with permission. All rights reserved. ©2023 Family Research Council.

The Washington Stand is Family Research Council’s outlet for news and commentary from a biblical worldview. The Washington Stand is based in Washington, D.C. and is published by FRC, whose mission is to advance faith, family, and freedom in public policy and the culture from a biblical worldview. We invite you to stand with us by partnering with FRC.

Rep. Massie, Judiciary Committee Launch Probe Into Reports Biden Admin Pressured FDA Over COVID Booster Approval

/in , , , , , , , , /by

Republican Kentucky Rep. Thomas Massie sent letters Monday to senior Food and Drug Administration (FDA) vaccine officials, letting them know the House Judiciary Committee will be investigating allegations the Biden administration interfered in the FDA’s authorization and licensure of the COVID-19 vaccines.

The Daily Caller first obtained the letters to Dr. Marion Gruber and Dr. Philip Krause, both of whom resigned following President Joe Biden’s announcement in August 2021 calling for adults to receive a COVID-19 booster shot, which Massie says “put undue pressure on FDA health officials to quickly authorize the vaccinations.”

Gruber serves as the Vice President of Public Health and Regulatory Science at the International AIDS Vaccine Initiative. Philip Krause sits on the Board of Directors of Mesoblast, Inc. Gruber had been with the FDA for 32 years and Krause had worked at the agency for over a decade.

In the letters, Massie calls for records and materials relating to: 1. The FDA’s review, authorization, approval and/or promotion of all COVID-19 vaccines and boosters; 2. The departure of Dr. Marion Gruber and Dr. Philip Krause from the FDA’s Office of Vaccines Research and Review (OVRR); and 3. The identities of current or former employees who worked in the FDA’s OVRR for the period of Jan. 1, 2020, to the present.

“The Committee on the Judiciary is investigating allegations that the Biden Administration interfered in the U.S. Food and Drug Administration’s (FDA) authorization and licensure of the COVID-19 vaccines,” Massie wrote in the letter to the FDA.

“Dr. Gruber and Dr. Krause reportedly felt that the White House was getting ahead of the FDA on booster shots and disagreed with the Centers for Disease Control and Prevention’s (CDC) involvement in FDA decisions. You replaced Dr. Gruber as acting director of the FDA’s Office of Vaccines Research and Review (OVRR). Accordingly, we believe that you possess information relating to this matter, and we request your assistance with our inquiry,” he added.

READ THE LETTERS HERE: 

(DAILY CALLER OBTAINED) — … by Henry Rodgers

(DAILY CALLER OBTAINED) — … by Henry Rodgers

“Congress has an obligation to examine these facts to understand the sufficiency of existing federal statutes and to assess the Executive Branch’s execution of these statutes. Pursuant to the Rules of the House of Representatives, the Committee on the Judiciary has jurisdiction to conduct oversight of matters concerning ‘civil liberties’ and ‘administrative practice and procedures’ to inform potential legislative reforms,” Massie added.

The Caller contacted the FDA, Mesoblast, Inc. and the International AIDS Vaccine Initiative about the letters, to which they did not immediately respond.

AUTHOR

HENRY RODGERS

Chief national correspondent. Follow Henry Rodgers On Twitter

RELATED TWEET:

RELATED ARTICLE: Two Top Vaccine Officials Resign From FDA Amid Political Pressure From Biden Administration

EDITORS NOTE: This Daily Caller column is republished with permission. ©All rights reserved.

All content created by the Daily Caller News Foundation, an independent and nonpartisan newswire service, is available without charge to any legitimate news publisher that can provide a large audience. All republished articles must include our logo, our reporter’s byline and their DCNF affiliation. For any questions about our guidelines or partnering with us, please contact licensing@dailycallernewsfoundation.org.

VIDEO: FDA Exec Exposes Close Ties Between Agency and Big Pharma

/in , , , , , , , , /by

*CLICK HERE TO TWEET OUT THE VIDEO*

Project Veritas released Part Two of its video series on the FDA today, which features FDA Executive Officer, Christopher Cole, speaking about the inner workings of the agency — including the FDA’s conflicts of interest, overspending, and why it’s hard for those within the agency to speak out on such abuses.

Here are some of the highlights from today’s video:

  • FDA Executive Officer, Christopher Cole: “The drug companies, the food companies, the vaccine companies. So, they pay us hundreds of millions of dollars a year to hire and keep the reviewers to approve their products.”
  • Cole on FDA fees: “Congress approved user fees for [the] FDA. Basically, we charge the industry millions of dollars in order to hire more drug reviewers and vaccine reviewers which will speed up the approval process. So, they [pharmaceutical companies] make more money.”
  • Cole: “They [FDA] tone down the impact of the user fees on their operations because they know they’re dependent on the drug companies, and the vaccine companies, and these other companies for their agency to operate.”
  • Cole on blowing the whistle: “There’s not an incentive to speak out in government, surprisingly. You would think there would be, but there’s not. It’s better just to just not say anything and just ignore it.”

You can watch the full video by HERE.

Cole’s LinkedIn page lists him as an Executive Officer within the agency’s Countermeasures Initiatives, which plays a critical role in ensuring that drugs, vaccines, and other measures to counter infectious diseases and viruses are safe. He made these revelations on a hidden camera to an undercover Project Veritas reporter.

A spokesperson for FDA issued a statement yesterday saying, “The person purportedly in the video does not work on vaccine matters and does not represent the views of the FDA.”

This statement appears to contradict a phone call released Wednesday afternoon by Project Veritas wherein Cole reiterated that he is “a manager in the office that helps oversee the approval of the COVID vaccines for emergency approval.”

Will the FDA clarify this situation? Only time will tell…

*CLICK HERE TO TWEET OUT THE VIDEO*

EDITORS NOTE: This Project Veritas video report is republished with permission. ©All rights reserved.

Over-the-Counter Ivermectin? It Could Be Coming to a State Near You—Despite FDA Concerns

/in , , , , , , , /by

The ivermectin controversy has sparked a wider debate about medical freedom.

A new bill recently introduced in New Hampshire would allow residents to get ivermectin from pharmacies without first getting a prescription or approval from a doctor. The legislation, titled House Bill 1022, is still in committee, but the state House of Representatives is slated to vote on it in the coming weeks.

The purpose of the bill is to provide wider access to ivermectin for those who want to take it as a treatment for COVID-19. Thus far, the Food and Drug Administration (FDA) has not approved the drug for treating COVID-19, but many believe it is an effective treatment and are eager to have it on hand should they be infected with the virus.

Though the FDA has not weighed in on this bill in particular, the agency has made it clear that they have serious concerns about the use of ivermectin for this purpose.

“The FDA has received multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock,” they write on their website. “Currently available data do not show ivermectin is effective against COVID-19,” they continue. “There’s a lot of misinformation around, and you may have heard that it’s okay to take large doses of ivermectin. It is not okay.”

The caution isn’t only coming from the FDA, however. As Newsweek reports, “a number of medical experts testified in opposition to the bill during a legislative session [in January].”

Part of the opposition is undoubtedly due to concerns about safety and efficacy, but there are also concerns about what the bill specifically allows and requires. To address these, the House committee is considering certain bipartisan amendments, such as “requiring that patients who receive the drug are informed that its use for COVID-19 is ‘off-label’ and setting guidelines for tracking any adverse effects.”

Though ivermectin received very little attention when the pandemic first broke out, its use in treating COVID-19 has become increasingly well known, and, in recent months, polarizing. In particular, the drug garnered significant public attention when comedian and podcaster Joe Rogan disclosed in September that he was using it to treat COVID-19 after getting a prescription from his doctor.

Rogan’s announcement led many CNN commentators to claim he was taking “horse dewormer”, since the drug is often used to treat parasites in horses and other livestock. This was misleading, however, since the drug is also approved for human use to treat certain infections.

The whole spat came to a head when Joe Rogan interviewed Dr. Sanjay Gupta, CNN’s chief medical correspondent, in October. “Does it bother you that the network you work for out and out lied, just outright lied about me taking horse dewormer?” Rogan asked Gupta. “They shouldn’t have said that,” Gupta replied. “Why did they do that?” Rogan pressed. “I don’t know,” Gupta responded.

CNN’s rhetoric aside, the question of whether it’s appropriate to prescribe ivermectin to COVID-19 patients remains divisive. A doctor in Virginia, for instance, recently resigned from his position at a medical school after losing a court battle over whether he could prescribe ivermectin for COVID-19. Meanwhile, a doctor in Minnesota who recently served in the Minnesota Senate and is now running for governor is under investigation for prescribing the drug to COVID-19 patients. And in Canada, a doctor has had his medical license restricted because of his views on COVID-19, and one of the restrictions is that he is not allowed to prescribe ivermectin.

Despite the pushback, many doctors in the US continue to prescribe the drug for COVID-19. One such physician is Dr. Joseph Varon, who is the chief medical officer at United Memorial Medical Center in Houston. “My love for [ivermectin] is based on my personal use and good outcomes my patients have had,” Dr. Varon told the Houston Chronicle back in August. “Once you see it work, it is difficult to deny its usefulness.”

But while many doctors support the treatment, many others are strongly against it. For instance, Dr. A. Clinton White, a professor of infectious disease at University of Texas Medical Branch, has said many of the trials that seem to show the benefits of ivermectin were “deeply flawed and likely reflected biases.”

This statement about the trials is worth noting, because it gets at one of the core problems with the whole debate. The problem is that the safety and efficacy of this treatment is fundamentally an empirical question, one that most of us simply aren’t qualified to speak to. Typically, the solution to this problem is to rely on experts who can interpret the data for us. But when the experts themselves disagree, there’s not much we can do except hope that the results of future trials will be more conclusive.

But while the jury may be out regarding the empirical data, the ethics of making this drug available are a completely different question, and this is a question lay persons can weigh in on.

The argument for allowing people to access ivermectin, or any drug for that matter, rests on the principle of self-ownership. As Murray Rothbard explains in For a New Liberty, “the right to self-ownership asserts the absolute right of each man, by virtue of his (or her) being a human being, to ‘own’ his or her own body; that is, to control that body free of coercive interference.”

This may sound simple enough, but it has profound implications. If you really own your body, that means you and you alone have the right to decide what goes in it and what doesn’t. If someone coercively prevents you from taking a drug, they are effectively saying they have a higher claim on your life than you do. And that holds true whether that someone is acting by themselves or on behalf of a government.

“When we give government the power to make medical decisions for us,” said Ron Paul, “we in essence accept that the state owns our bodies.”

Another phrase that’s often used for the self-ownership position is bodily autonomy. Notably, the word “autonomy” comes from the Greek words auto, which means “self”, and nomos, which means “law.” So in essence, autonomy is about having a “self-law” or being “self-governing”.

Now, many people give lip service to the idea of bodily autonomy with phrases like “my body, my choice.” But holding that principle consistently means removing all restrictions about what people can do with their body. After all, you can’t be “self-governing” if you’re simultaneously being governed by other people.

Of course, some people will use their freedom to make bad choices and will have to suffer the consequences, but this is nothing new. We let people take all sorts of health and safety risks out of respect for their autonomy, such as with diet, alcohol consumption, smoking habits, and extreme sports.

And while some people may use their freedom to make bad choices, many others will use it to make good choices that the government is currently preventing them from making, such as taking drugs that could save their life.

Now, whether ivermectin is one of those lifesaving drugs is currently up for debate. But what shouldn’t be up for debate is each individual’s right to make their own medical decisions.

COLUMN BY

Patrick Carroll

Patrick Carroll has a degree in Chemical Engineering from the University of Waterloo and is an Editorial Fellow at the Foundation for Economic Education.

RELATED ARTICLES:

ALERT: Israel Proves Covid ‘Vaccines’ are Ineffective and Dangerous – Boosters Must Stop!

INFOGRAPHIC: Approved and Non-FDA Approved COVID-19 Treatments

RELATED TWEET:

EDITORS NOTE: This MercatorNet column is republished with permission. ©All rights reserved.

Well, Back to Smoking: FDA Bans 99 Percent of E-Cigarettes by Guy Bentley

/in , , , , /by

The Food and Drug Administration (FDA) published long-awaited rules Thursday that could ban 99 percent of e-cigarette products and wreck industry innovation for years to come.

Passed in 2009, the Tobacco Control Act says all e-cigarette products released after February 15, 2007, (predicate date) will have to go through the Pre-Market Tobacco Applications process (PMTA). FDA officials claim they cannot change the predicate date.

The PMTA is ruinously expensive and can cost millions of dollars per product and by the FDA’s own admission will take more than 1,700 hours for an applicant to complete.

Since almost all vapor products on the market were released after February 2007, hardly any will avoid a PMTA and almost no businesses, with the exception of big tobacco companies, will be able to bear the regulatory burden.

“The agency’s economic analysis of the rule predicts that the cost of such approvals will be so high that approximately 99 percent of products on the market will not even be put through the application process,” says the American Vaping Association (AVA).

The rules usher in a new era of federal regulation, with sales of vapor products to those under the age of 18 banned nationwide. Most states had already passed laws banning e-cigarette sales to minors.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a press release. The FDA will now set industry standards for manufacturing and labeling. The rules will take effect in 90 days.

But there is still hope for the industry yet after a House Appropriations committee passed an amendment April 19, which would alter the predicate date. The amendment is not yet law and will have to pass through the House of Representatives.

If the amendment fails however and the FDA regulations stand, the industry will have two years to comply with the PMTA.

“Despite an overabundance of distorted and misleading information propagated by some in the public health community, the science is clear – responsibly manufactured vapor products are not only a safer alternative to traditional combustible products, but also provide smokers with a viable path to reducing their tobacco consumption and quitting altogether,” said Tony Abboud, the Vapor Technology Association’s National Legislative Director.

“Today’s action by the FDA will do nothing to improve our nations’ public health objectives. To the contrary, today’s action will yank responsibly manufactured vapor products from the hands of adult smokers and replace them with the tobacco cigarettes they had been trying to give up.”

The VTA argue the FDA’s rules will kill almost a decade of innovation in the e-cigarette space and put thousands of small and mid-size businesses out of businesses to the benefit of major tobacco companies.

“If, in the name of public health, federal regulations inhibit much-needed innovation in the e-cigarette market, public health would actually suffer, as fewer adult smokers would be likely to switch from smoking,” said the National Center for Public Policy Research’s director of Risk Analysis, Jeff Stier.

“One only needs to look at the rapid innovation coming from the vaping industry to see how devastating this rule will be,” Jared Meyer, Fellow at the Manhattan Institute, told The Daily Caller News Foundation in an emailed statement.

“While large tobacco companies will likely be able to absorb these costs, countless small manufacturers will be put out of business – leading to a less dynamic market. Without continued innovation, it will be harder from cigarette smokers to kick their deadly habit by taking up a much less harmful form of nicotine consumption,” Meyer added.

According to Wells Fargo, e-cigarette sales amounted to $3.5 billion in 2015. The case for wide-spread e-cigarette use was given a boost April 27 after the Royal College of Physicians published a 200-page report supporting the products as a smoking cessation method.

Reprinted with permission  from the Daily Caller News Foundation.

Guy BentleyGuy Bentley

Guy Bentley is a reporter for the Daily Caller.

A Deadly Caution: How the FDA’s Precautionary Principle Is Killing Patients by Alexander Tabarrok

/in , , , , , /by

I have long argued that the FDA has an incentive to delay the introduction of new drugs because approving a bad drug (Type I error) has more severe consequences for the FDA than does failing to approve a good drug (Type II error).

In the former case, at least some victims are identifiable and the New York Times writes stories about them and how they died because the FDA failed. In the latter case, when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible graveyard.

In an excellent new paper (also here), Vahid Montazerhodjat and Andrew Lo use a Bayesian analysis to model the optimal tradeoff in clinical trials between sample size, Type I and Type II error.

Failing to approve a good drug is more costly, for example, the more severe the disease. Thus, for a very serious disease, we might be willing to accept a greater Type I error in return for a lower Type II error. The number of people with the disease also matters. Holding severity constant, for example, the more people with the disease the more you want to increase sample size to reduce Type I error. All of these variables interact.

In an innovation, the authors use the US Burden of Disease Study to find the number of deaths and the disability severity caused by each major disease. Using this data, they estimate the costs of failing to approve a good drug. Similarly, using data on the costs of adverse medical treatment, they estimate the cost of approving a bad drug.

Putting all this together the authors find that the FDA is often dramatically too conservative:

We show that the current standards of drug-approval are weighted more on avoiding a Type I error (approving ineffective therapies) rather than a Type II error (rejecting effective therapies).

For example, the standard Type I error of 2.5% is too conservative for clinical trials of therapies for pancreatic cancer — a disease with a 5-year survival rate of 1% for stage IV patients (American Cancer Society estimate, last updated 3 February 2013).

The BDA-optimal size for these clinical trials is 27.9%, reflecting the fact that, for these desperate patients, the cost of trying an ineffective drug is considerably less than the cost of not trying an effective one.

(The authors also find that the FDA is occasionally a little too aggressive, but these errors are much smaller: for example, the authors find that for prostate cancer therapies the optimal significance level is 1.2% compared to a standard rule of 2.5%.)

The result is important especially because, in a number of respects, the authors underestimate the costs of FDA conservatism.

Most importantly, the authors are optimizing at the clinical trial stage assuming that the supply of drugs available to be tested is fixed. Larger trials, however, are more expensive, and the greater the expense of FDA trials, the fewer new drugs will be developed. Thus, a conservative FDA reduces the flow of new drugs to be tested.

In a sense, failing to approve a good drug has two costs: the opportunity cost oflives that could have been saved and the cost of reducing the incentive to invest in R&D.

In contrast, approving a bad drug, while still an error, at least has the advantage of helping to incentivize R&D (similarly, a subsidy to research incentivizes R&D in a sense mostly by covering the costs of failed ventures).

The Montazerhodjat and Lo framework is also static: there is one test and then the story ends.

In reality, drug approval has an interesting asymmetric dynamic. When a drug is approved for sale, testing doesn’t stop but moves into another stage, a combination of observational testing and sometimes more RCTs — this, after all, is how adverse events are discovered. Thus, Type I errors are corrected.

On the other hand, for a drug that isn’t approved, the story does end. With rare exceptions, Type II errors are never corrected.

The Montazerhodjat and Lo framework could be interpreted as the reduced form of this dynamic process, but it’s better to think about the dynamism explicitly because it suggests that approval can come in a range for forms — for example, approval with a black label warning, approval with evidence grading, and so forth. As these procedures tend to reduce the costs of Type I errors, they tend to increase the costs of FDA conservatism.

Montazerhodjat and Lo also don’t examine the implications of heterogeneity of preferences or diseases morbidity and mortality. Some people, for example, are severely disabled by diseases that on average aren’t very severe — the optimal tradeoff for these patients will be different than for the average patient. One size doesn’t fit all.

In the standard framework, it’s tough luck for these patients. But if the non-FDA reviewing apparatus (patients/physicians/hospitals/HMOs/USP/Consumer Reports, and so forth) works relatively well — and this is debatable, but my work on off-label prescribing suggests that it does — this weighs heavily in favor of relatively large samples but low thresholds for approval.

What the FDA is really providing is information, and we don’t need product bans to convey information. Thus, heterogeneity (plus a reasonable effective post-testing choice process) mediates in favor of a Consumer Reports model for the FDA.

The bottom line, however, is that even without taking into account these further points, Montazerhodjat and Lo find that the FDA is far too conservative, especially for severe diseases. FDA regulations may appear to be creating safe and effective drugs, but they are also creating a deadly caution.

Hat tip: David Balan.

A version of this post first appeared at the Marginal Revolution blog.

Alex Tabarrok
Alex Tabarrok

Alex Tabarrok is a professor of economics at George Mason University. He blogs at Marginal Revolution with Tyler Cowen.

Video Game Developers Face the Final Boss: The FDA by Aaron Tao

/in , , , , , , /by

As I drove to work the other day, I heard a very interesting segment on NPR that featured a startup designing video games to improve cognitive skills and relieve symptoms associated with a myriad of mental health conditions.

One game, Project Evo, has shown good preliminary results in training players to ignore distractions and stay focused on the task at hand:

“We’ve been through eight or nine completed clinical trials, in all cognitive disorders: ADHD, autism, depression,” says Matt Omernick, executive creative director at Akili, the Northern California startup that’s developing the game.

Omernick worked at Lucas Arts for years, making Star Wars games, where players attack their enemies with light sabers. Now, he’s working on Project Evo. It’s a total switch in mission, from dreaming up best-sellers for the commercial market to designing games to treat mental health conditions.

“The qualities of a good video game, things that hook you, what makes the brain — snap — engage and go, could be a perfect vessel for actually delivering medicine,” he says.

In fact, the creators believe their game will be so effective it might one day reduce or replace the drugs kids take for ADHD.

This all sounds very promising.

In recent years, many observers (myself included) have expressed deep concerns that we are living in the “medication generation,” as defined by the rapidly increasing numbers of young people (which seems to have extended to toddlers and infants!) taking psychotropic drugs.

As experts and laypersons continue to debate the long-term effects of these substances, the news of intrepid entrepreneurs creating non-pharmaceutical alternatives to treat mental health problems is definitely a welcome development.

But a formidable final boss stands in the way:

[B]efore they can deliver their game to players, they first have to go through the Food and Drug Administration — the FDA.

The NPR story goes on to detail on how navigating the FDA’s bureaucratic labyrinth is akin to the long-grinding campaign required to clear the final dungeon from any Legend of Zelda game. Pharmaceutical companies are intimately familiar with the FDA’s slow and expensive approval process for new drugs, and for this reason, it should come as no surprise that Silicon Valley companies do their best to avoid government regulation. One venture capitalist goes so far as to say, “If it says ‘FDA approval needed’ in the business plan, I myself scream in fear and run away.”

Dynamic, nimble startups are much more in tune with market conditions than the ever-growing regulatory behemoth that is defined by procedure, conformity, and irresponsibility. As a result, conflict between these two worlds is inevitable:

Most startups can bring a new video game to market in six months. Going through the FDA approval process for medical devices could take three or four years — and cost millions of dollars.

In the tech world, where app updates and software patches are part of every company’s daily routine just to keep up with consumer habits, technology can become outdated in the blink of an eye. Regulatory hold on a product can spell a death sentence for any startup seeking to stay ahead of its fierce market competition.

Akili is the latest victim to get caught in the tendrils of the administrative state, and worst of all, in the FDA, which distinguished political economist Robert Higgs has described as “one of the most powerful of federal regulatory agencies, if not the most powerful.” The agency’s awesome authority extends to over twenty-five percent of all consumer goods in the United States and thus “routinely makes decisions that seal the fates of millions.”

Despite its perceived image as the nation’s benevolent guardian of health and well-being, the FDA’s actual track record is anything but, and its failures have been extensively documented in a vast economic literature.

The “knowledge problem” has foiled the whims of central planners and social engineers in every setting, and the FDA is not immune. By taking a one-sized-fits-all approach in enacting regulatory policy, it fails to take into account the individual preferences, social circumstances, and physiological attributes of the people that compose a diverse society.

For example, people vary widely in their responses to drugs, depending on variables that range from dosage to genetic makeup. In a field as complex as human health, an institution forcing its way on a population is bound to cause problems (for a particularly egregious example, see what happened with the field of nutrition).

The thalidomide tragedy of the 1960s is usually cited as to why we need a centralized, regulatory agency staffed by altruistic public servants to keep the market from being flooded by toxins, snake oils, and other harmful substances. However, this needs to be weighed against the costs of keeping beneficial products withheld.

For example, the FDA’s delay of beta blockers, which were widely available in Europe to reduce heart attacks, was estimated to have cost tens of thousands of lives. Despite this infamous episode and other repeated failures, the agency cannot overcome the institutional incentives it faces as a government bureaucracy. These factors strongly skew its officials towards avoiding risk and getting blamed for visible harm. Here’s how the late Milton Friedman summarized the dilemma with his usual wit and eloquence:

Put yourself in the position of a FDA bureaucrat considering whether to approve a new, proposed drug. There are two kinds of mistakes you can make from the point of view of the public interest. You can make the mistake of approving a drug that turns out to have very harmful side effects. That’s one mistake. That will harm the public. Or you can make the mistake of not approving a drug that would have very beneficial effects. That’s also harmful to the public.

If you’re such a bureaucrat, what’s going to be the effect on you of those two mistakes? If you make a mistake and approve a product that has harmful side effects, you are a devil incarnate. Your misdeed will be spread on the front page of every newspaper. Your name will be mud. You will get the blame. If you fail to approve a drug that might save lives, the people who would object to that are mostly going to be dead. You’re not going to hear from them.

Critics of America’s dysfunctional healthcare system have pointed out the significant role of third-party spending in driving up prices, and how federal and state regulations have created perverse incentives and suppressed the functioning of normal market forces.

In regard to government restrictions on the supply of medical goods, the FDA deserves special blame for driving up the costs of drugs, slowing innovation, and denying treatment to the terminally ill while demonstrating no competency in product safety.

Going back to the NPR story, a Pfizer representative was quoted in saying that “game designers should go through the same FDA tests and trials as drug manufacturers.”

Those familiar with the well-known phenomenon of regulatory capture and the basics of public choice theory should not be surprised by this attitude. Existing industries, with their legions of lobbyists, come to dominate the regulatory apparatus and learn to manipulate the system to their advantage, at the expense of new entrants.

Akili and other startups hoping to challenge the status quo would have to run past the gauntlet set up by the “complex leviathan of interdependent cartels” that makes up the American healthcare system. I can only wish them the best, and hope Schumpeterian creative destruction eventually sweeps the whole field of medicine.

Abolishing the FDA and eliminating its too-often abused power to withhold innovative medical treatments from patients and providers would be one step toward genuine healthcare reform.

A version of this post first appeared at The Beacon.

Aaron Tao
Aaron Tao

Aaron Tao is the Marketing Coordinator and Assistant Editor of The Beacon at the Independent Institute. Follow him on Twitter here.

5 Reasons the FDA’s Ban on Trans Fat Is a Big Deal by Walter Olson

/in , , /by

The Obama administration’s Food and Drug Administration today announced a near-ban, in the making since 2013, on the use of partially hydrogenated vegetable fats (“trans fats”) in American food manufacturing.

Specifically, the FDA is knocking trans fats off the Generally Recognized as Safe (GRAS) list. This is a big deal and here are some reasons why:

1. It’s frank paternalism. Like high-calorie foods or alcoholic beverages, trans fats have marked risks when consumed in quantity over long periods, smaller risks in moderate and occasional use, and tiny risks when used in tiny quantities. The FDA intends to forbid the taking of even tiny risks, no matter how well disclosed.

2. The public doesn’t agree. A 2013 Reason-RUPE poll found majorities of all political groups felt consumers should be left free to choose on trans fats.  Even in heavily governed places like New York City and California, where the political class bulldozed through restaurant bans some years back, there was plenty of resentment.

3. The public is also perfectly capable of recognizing and acting on nutritional advances on its own. Trans fats have gone out of style and consumption has dropped by 85 percent as consumers have shunned them.

But while many products have been reformulated to omit trans fats, their versatile qualities still give them an edge in such specialty applications as frozen pizza crusts, microwave popcorn, and the sprinkles used atop cupcakes and ice cream. Food companies tried to negotiate to keep some of these uses available, especially in small quantities, but apparently mostly failed.

4. Government doesn’t always know best, nor do its friends in “public health.” The story has often been told of how dietary reformers touted trans fats from the 1950s onward as a safer alternative to animal fats and butter.

Public health activists and various levels of government hectored consumers and restaurants to embrace the new substitutes. We now know this was a bad idea: trans fats appear worse for cardiovascular health than what they replaced. And the ingredients that will replace minor uses of trans fats – tropical palm oil is one – have problems of their own.

5. Even if you never plan to consume a smidgen of trans fat ever again, note well: many public health advocates are itching for the FDA to limit allowable amounts of salt, sugar, caffeine, and so forth in food products. Many see this as their big pilot project and test case.

But when it winds up in court, don’t be surprised if some courtroom spectators show up wearing buttons with the old Sixties slogan: Keep Your Laws Off My Body.


Walter Olson

Walter Olson is a senior fellow at the Cato Institute’s Center for Constitutional Studies.

EDITORS NOTE: This post first appeared at Cato.org.

Who Should Choose? Patients and Doctors or the FDA? by Doug Bandow

/in , , , , , , /by

Good ideas in Congress rarely have a chance. Rep. Fred Upton (R-Mich.) is sponsoring legislation to speed drug approvals, but his initial plan was largely gutted before he introduced it last month.

Congress created the Food and Drug Administration in 1906, long before prescription drugs became such an important medical treatment. The agency became an omnibus regulatory agency, controlling everything from food to cosmetics to vitamins to pharmaceuticals. Birth defects caused by the drug Thalidomide led to the 1962 Kefauver-Harris Amendments which vastly expanded the FDA’s powers. The new controls did little to improve patient safety but dramatically slowed pharmaceutical approvals.

Those who benefit the most from drugs often complain about the cost since pills aren’t expensive to make. However, drug discovery is an uncertain process. Companies consider between 5,000 and 10,000 substances for every one that ends up in the pharmacy. Of those only one-fifth actually makes money—and must pay for the entire development, testing, and marketing processes.

As a result, the average per drug cost exceeds $1 billion, most often thought to be between $1.2 and $1.5 billion. Some estimates run more.

Naturally, the FDA insists that its expensive regulations are worth it. While the agency undoubtedly prevents some bad pharmaceuticals from getting to market, it delays or blocks far more good products.

Unfortunately, the political process encourages the agency to kill with kindness. Let a drug through which causes the slightest problem, and you can expect television special reports, awful newspaper headlines, and congressional hearings. Stop a good drug and virtually no one notices.

It took the onset of AIDS, then a death sentence, to force the FDA to speed up its glacial approval process. No one has generated equivalent pressure since. Admitted Richard Merrill, the agency’s former chief counsel:  “No FDA official has ever been publicly criticized for refusing to allow the marketing of a drug.”

By 1967 the average delay in winning approval of a new drug had risen from seven to 30 months after the passage of Kefauver-Harris. Approval time now is estimated to run as much as 20 years.

While economist Sam Peltzman figured that the number of new drugs approved dropped in half after Kefauver-Harris, there was no equivalent fall in the introduction of ineffective or unsafe pharmaceuticals. All the Congress managed to do was strain out potentially life-saving products.

After all, a company won’t make money selling a medicine that doesn’t work. And putting out something dangerous is a fiscal disaster. Observed Peltzman:  the “penalties imposed by the marketplace on sellers of ineffective drugs prior to 1962 seem to have been enough of a deterrent to have left little room for improvement by a regulatory agency.”

Alas, the FDA increases the cost of all medicines, delays the introduction of most pharmaceuticals, and prevents some from reaching the market. That means patients suffer and even die needlessly.

The bureaucracy’s unduly restrictive approach plays out in other bizarre ways. Once a drug is approved doctors may prescribe it for any purpose, but companies often refuse to go through the entire process again to win official okay for another use. Thus, it is common for AIDS, cancer, and pediatric patients to receive off-label prescriptions. However, companies cannot advertise these safe, effective, beneficial uses.

Congress has applied a few bandages over the years. One was to create a process of user fees through the Prescription Drug User Fee Act. Four economists, Tomas Philipson, Ernst Berndt, Adrian Gottschalk, and Matthew Strobeck, figured that drugmakers gained between $11 billion and $13 billion and consumers between $5 billion and $19 billion. Total life years saved ranged between 180,000 and 310,000. But lives continue to be lost because the approval process has not been accelerated further.

Criticism and pressure did lead to creation of a special FDA procedure for “Accelerated Approval” of drugs aimed at life-threatening conditions. This change, too, remains inadequate. Nature Biotechnology noted that few medicines qualified and “in recent years, FDA has been ratcheting up the requirements.”

The gravely ill seek “compassionate access” to experimental drugs. Some patients head overseas unapproved treatments are available. The Wall Street Journal reported on those suffering from Lou Gehrig’s disease who, “frustrated by the slow pace of clinical drug trials or unable to qualify, are trying to brew their own version of an experimental compound at home and testing it on themselves.”

Overall, far more people die from no drugs than from bad drugs. Most pharmaceutical problems involve doctors misprescribing or patients misusing medicines. The deadliest pre-1962 episode involved Elixir Sulfanilamide and killed 107 people. (Thalidomide caused some 10,000 birth defects, but no deaths.) Around 3500 users died from Isoproterenol, an asthmatic inhaler. Vioxx was blamed for a similar number of deaths, though the claim was disputed. Most of the more recent incidents would not have been prevented from a stricter approval process.

The death toll from agency delays is much greater. Drug analyst Dale Gieringer explained:  “The benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade or 10,000 per decade for worst-case scenarios.  In comparison … the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade.”

According to the Competitive Enterprise Institute, among the important medicines delayed were ancrod, beta-blockers, citicoline, ethyol, femara, glucophage, interleukin-2, navelbine, lamictal, omnicath, panorex, photofrin, prostar, rilutek, taxotere, transform, and vasoseal.

Fundamental reform is necessary. The FDA should be limited to assessing safety, with the judgment as to efficacy left to the marketplace. Moreover, the agency should be stripped of its approval monopoly. As a start drugs approved by other industrialized states should be available in America.

The FDA’s opinion also should be made advisory. Patients and their health care providers could look to private certification organizations, which today are involved in everything from building codes to electrical products to kosher food. Medical organizations already maintain pharmaceutical databases and set standards for treatments with drugs. They could move into drug testing and assessment.

No doubt, some people would make mistakes. But they do so today. With more options more people’s needs would be better met. Often there is no single correct treatment decision. Ultimately the patient’s preference should control.

Congress is arguing over regulatory minutiae when it should be debating the much more basic question: Who should decide who gets treated how? Today the answer is Uncle Sam. Tomorrow the answer should be all of us.

Doug Bandow

Doug Bandow is a senior fellow at the Cato Institute and the author of a number of books on economics and politics. He writes regularly on military non-interventionism.

FDA-generated Stevia Myth

/in , , /by

One recent “viral” email making the rounds claims that the natives of Paraguay have used the intense sweetener stevia as a contraceptive and that it can cause infertility. This raises suspicions because primitive societies are known for performing fertility rites so that women will reproduce. Primitive societies generally would never do just the opposite and seek a contraceptive method.

The FDA works hand in glove with the sweetener manufacturers, also warns that a supposed infertility effect is ascribed to stevia (with no data to back this claim), and has so far refused to assign it the GRAS (Generally Recognized as Safe) designation.

I have been translating patents relating to sweeteners for about 35 years and it would be hard to maintain that I am not a specialist on this subject. Interestingly, while patents relating to aspartame and sucralose (artificial sweeteners sold, for ex, as NutraSweet or Equal and as Splenda) often mention the known untoward effects of these substances, none of the patents (Japanese, German, Chinese, French, etc.) that I have translated mention any health drawbacks of stevia. If you try to tell a Japanese, for example, that you think stevia is unsafe, they will think you are insane. Their medical profession does its homework and would never fail to report any untoward side effects of stevia if there were any.

Stevia is a natural sweetener whose sweet principles (stevioside and rebaudioside) are the only intense sweeteners in nature without an off-taste. (Licorice, for ex, is also a natural sweetener but its sweet principle glycyrrhizin has a peculiar off taste. Non-intense sweeteners, or bulk sweeteners, are generally sugar alcohols such as xylitol, mannitol, maltitol, etc., and we aren’t discussing them here).

Stevia is a plant that grows to about a foot or more and its leaves are sweet. I have grown it myself to sweeten my coffee.

It is indigenous to Paraguay and the natives have been using it as a sweetener for years.

It is grown in various parts of South America, Asia and elsewhere, and is marketed in various countries. I believe it is available in the U.S. but the FDA refuses to classify it as GRAS. This is highly unusual because almost all natural substances that have been used for centuries in any country are automatically classified as GRAS by the FDA unless the native people who have used it have reported side effects. No Guarani Indians have issued such reports and they have used it for centuries. Further, according to the EUFIC, stevia sweeteners are approved for use in many countries including Japan, Korea, Taiwan, China, Russia, Mexico, Argentina, Colombia, Peru, Paraguay, Uruguay, Brazil and Malaysia.

So why might the FDA be out of step with the world?

Well, both Splenda and Nutrasweet / Equal are sold by American companies (JW Childs, Boston, and Merisant). In the case of Splenda, there is a British component in a joint venture, namely, Tate and Lyle, but Johnson & Johnson also sells it.

On the other hand, aspartame, which is known to be harmful to phenylketonurics and actually carries an FDA warning to that effect, is listed as GRAS by the FDA.

This is very suspicious to me.

Here is what Wikipedia says, raising more suspicion.

In 1991, after receiving an anonymous industry complaint, the United States Food and Drug Administration (FDA) labeled stevia as an “unsafe food additive” and restricted its import [THIS IS OUTRAGEOUS. AN ‘ANONYMOUS’ COMPLAINT DOES NOT MERIT SUCH A RESPONSE! — DON],.[40][59][60] The FDA’s stated reason was “toxicological information on stevia is inadequate to demonstrate its safety.”[61]

Since the import ban in 1991, marketers and consumers of stevia have shared a belief that the FDA acted in response to industry pressure.[40] Arizona congressman Jon Kyl, for example, called the FDA action against stevia “a restraint of trade to benefit the artificial sweetener industry”.[62] To protect the complainant, the FDA deleted names in the original complaint in its responses to requests filed under the Freedom of Information Act.[40]

Stevia remained banned until after the Dietary Supplement Health and Education Act of 1994 forced the FDA in 1995 to revise its stance to permit stevia to be used as a dietary supplement, although not as a food additive – a position that stevia proponents regarded as contradictory because it simultaneously labeled stevia as safe and unsafe, depending on how it was sold.[7]

Early studies prompted the European Commission in 1999 to ban stevia’s use in food in the European Union pending further research.[63] In 2006, research data compiled in the safety evaluation released by the World Health Organization found no adverse effects.[33] Since 2008, the Russian Federation has allowed stevioside as a food additive “in the minimal dosage required”.[51]

In December 2008, the FDA gave a “no objection” approval for GRAS status to Truvia (developed by Cargill and The Coca-Cola Company) and PureVia (developed by PepsiCo and the Whole Earth Sweetener Company, a subsidiary of Merisant), both of which use rebaudioside A derived from the Stevia plant.[64] However, FDA said that these products are not Stevia, but a highly purified product [THAT IS NONSENSE. STEVIA IS NEVER SOLD IN UNPURIFIED FORM. IT TASTES TOO BITTER FOR THAT. IN FACT, IN THE BUSINESS, STEVIA SWEET PRINCIPLES ARE SIMPLY CALLED STEVIA. THIS IS JUST AN EXCUSE FOR THE FDA TO WRIGGLE OUT OF ITS ORIGINAL BAN ON THE PRODUCT!–DON].[65] In 2012, FDA posted a note on its website regarding crude Stevia plant: “FDA has not permitted the use of whole-leaf Stevia or crude Stevia extracts because these substances have not been approved for use as a food additive. FDA does not consider their use in food to be GRAS in light of reports in the literature that raise concerns about the use of these substances. Among these concerns [NOTE: BASED ON AN ANONYMOUS REPORT, AS STATED ABOVE BY FDA. THAT IS OUTRAGEOUS BEYOND BELIEF–DON] are control of blood sugar and effects on the reproductive, cardiovascular, and renal systems.”[66]

So how has this stevia scare affected me personally? Right now, I am now sipping ice tea sweetened with stevia.