A Funny Thing Happened on Plan B One Step’s Way to the Drugstore Shelves…

Headline Washington, Thursday 8 December 2011- President Obama, who took office pledging to put science ahead of politics, averted a skirmish with conservatives in the nation’s culture wars on Thursday by endorsing his health secretary’s decision to block over-the-counter sales of an after-sex contraceptive pill to girls under age 17. www.truth-out.org

No doubt you’ve heard of the Obama Administration’s move to override the FDA’s decision to allow the “morning after pill” to be sold over the counter. It surprised the heck out of Teva Women’s Health, Inc., makers of Plan B One Step, when they heard their preparations to take the drug OTC were for nothing. One word came to mind when I heard about the decision: politics. Supporters of the decision say it’s a good idea because a pharmacist can still sell it to anyone who can prove they are at least 17 years old. Like many others who are uncomfortable with the idea of lifting the age restrictions on the sale of this product, Obama balked at the idea of a 10 or 11 year old being able to buy it “alongside bubblegum or batteries”. But there’s an election year coming up; my guess is that the president is ducking a 100% guaranteed confrontation by making sure One Step remains right where it is – behind the counter.

The FDA’s recommendation that the emergency contraceptive be available over the counter without age restriction was based on their research that said the pill was safe and effective for nonprescription use and that adolescents could use it properly without the intervention of a healthcare provider. Then the secretary of Health and Human Services (HHS), Kathleen Sebelius, stepped in. According to the British newspaper, The Guardian, Sebelius “was concerned that the manufacturer had not studied whether 11-year-olds, some of whom are capable of bearing children, would fully comprehend the product’s label and appropriate use.” Obama was very careful with his response; he voiced support for the Sebelius move while distancing himself from it. “As the father of two young daughters, I think it’s important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine,” he said. He also made it a point to say that he was not involved in the decision; he had left it up to Sebelius.

When it came to issues like stem cells, climate change, sex education and contraceptives, Bush’s administration watered down or outright suppressed the findings of government scientific agencies. So naturally the scientific community rejoiced when Obama vowed to “restore science to its rightful place” in his 2008 inaugural address. He has also said that he would ensure “that scientific data is never distorted or concealed to serve a political agenda.” But the evidence that Plan B is safe, effective and easy to use suggests that the Sebelius decision was not determined by science at all. Plan B works by suppressing ovulation and is 89% effective in preventing pregnancy if taken within 72 hours of unprotected sex. It has no serious side effects and will not terminate a pregnancy that has already begun. Plan B, therefore, is a contraceptive, not an instant abortion pill, as some anti-choice groups would have us believe. Quite the contrary. Research by the University of Chicago shows that since 2006, when emergency contraception was made widely available, it “lowered the risk of unintended pregnancy…and played a significant role in the decline of abortion between 2005 and 2007.” Moreover, a 2009 study in the journal Obstetrics and Gynecology showed that women and girls as young as 12 have consistently demonstrated a good understanding of how the drug is used and when they should use it. Sounds like good scientific evidence to me, but despite the findings of these and other studies, Sebelius nixed greater accessibility to the drug and cited “scientific uncertainty” to justify her action.

I suppose we could argue all day about how certain “scientific certainty” is, anyway. But the fact is that the FDA routinely approves drugs before every bit of research that could be done on them has been done. Many medications on the market have not been assessed for safety and efficacy for use in children, for example, or for women or people over 65. The difference is that with Plan B we’re talking about sexually active 11 year-old girls who are capable of becoming pregnant. There’s an “ick” factor here – discomfort with the idea of adolescents having sex lives and becoming parents. The Washington Post reported that Obama aides admitted that the decision wasn’t about science, but about a “gut feeling that teenagers might not be ready to make decisions about pregnancy.” Guess what, Mr. President, the minute adolescents choose to have sex they are making a decision about pregnancy – no matter how ill-informed or unconscious that decision may be. And speaking of ideas that are of questionable scientific merit – many Americans still believe that providing access to sex education and contraception will give kids the idea sex at any age is OK, so we have curtailed access. My grandson, for instance, just completed a sex ed module in his 7th grade health class. A permission slip was sent home for me to sign, outlining the content of the lessons. The subject of birth control was not mentioned. Parents had objected, apparently – too many kids having sex too early. The American Public Health Association reports that 33% of teens have had sex by 9th grade. That’s age 14, folks. Something tells me that refusing to educate kids about birth control isn’t working.When Obama and Sebelius refused to put themselves on the record by saying that making Plan B available OTC to adolescents made sense, they were simply refusing to grab hold of the teenage sex/contraception/abortion hot potato. Taking a stand means risking controversy, criticism and votes. So as politicians are wont to do, they took the easy way out and rejected the science on Plan B based on claims of “scientific uncertainty”. Slick.

The FDA decision promised to poke a great, big hole in America’s provincial attitude about sex but for now, anyway, Plan B One Step will remain off drugstore shelves. That’s unfortunate because wider access to the drug would be a safe, effective way to reduce the teenage pregnancy rate. And that rate, despite our collective head-burying, is on the rise. As long as the Obama administration continues to make women’s health decisions based on politics, we will continue to maintain the status quo. Looks like religion, emotion and kneejerk reactions trump science once again.

Yaz – The Sad and Sorry Saga of America’s Best-Selling Oral Contraceptive

If you were a woman between the years of 15-25 and in the market for an oral contraceptive, you might very well ask your doctor for a product called “Yaz”, and you’d have plenty of company. The maker of Yaz, Bayer Health Care Pharmaceuticals, enjoys $1.8 billion in sales from the drug annually. No wonder. Females between 15 and 25 years of age have been targeted by Bayer’s formidable advertising campaign and promised much more than just a contraceptive. Yaz is Bayer’s “magic pill”. But the real question should be, “Magic for whom?”

The boys at Bayer may have perked your interest when you were watching “Grey’s Anatomy” or some other prime-time TV show and saw an ad for their contraceptive wonder drug. They claimed Yaz to be “Beyond Birth Control”. Yaz isn’t just about preventing pregnancy – it’s about your LIFESTYLE. You know those nasty pre-menstrual symptoms? Bloating. Fatigue. Muscle aches. Headaches. Increased appetite. Anxiety. Irritability. Moodiness? Step right up, ladies, and get your bottle of Yaz. Guaranteed to treat every pre-menstrual symptom you’ve got. And as a bonus your skin will clear up, too! After a sales pitch like that, who wouldn’t run to their OB/GYN and ask for a prescription? The trouble is that Yaz is no better at preventing symptoms of pre-menstrual syndrome (PMS) or curing acne than a sugar pill. And Bayer knows it.

In 2009 the Food and Drug Administration (FDA) and the attorneys general of 27 states required Bayer to run new ads to correct their claims. “Regulators,” according to the New York Times, “say the ads overstated the drug’s ability to improve women’s moods and clear up acne, while playing down its potential health risks.” You can say that again. Side effects associated with Yaz include depression, migraines, breast lumps, high blood pressure and cholesterol, vaginal bleeding, hair loss, weight gain, cervical cancer, potentially life-threatening allergic reactions, liver damage, pulmonary embolism, deep vein thrombosis and blood clots that cause strokes, vision problems and heart attacks. Experts say lawsuits for health-damaging side effects may well reach 25,000 or more before all is said and done. And that number doesn’t include the numbers of women afraid or reluctant to file a claim against Bayer.

Take the story of Carissa Ubersox. In 2007 she graduated with a degree in nursing and went to work in pediatrics. On Christmas Day of that year her boyfriend surprised her with a ring while she worked the day shift. Dreaming about the big day and wanting to look her best, Carissa switched to Yaz after watching a commercial that promised it would help with bloating and acne. “Yaz is the only birth control proven to treat the physical and emotional premenstrual symptoms that are severe enough to impact your life,” claimed the ad. Carissa was taken in. Three months later, in February of 2008, Carissa’s legs began to ache. She didn’t pay much attention at first, attributing the pain to working 12 hour shifts on her feet. Then one evening she found herself gasping for air. Blood clots in her legs had traveled to her lungs and caused a massive double pulmonary embolism. Her fiancé called 911 but on the way to the hospital her heart stopped. She was revived but slipped into a coma for two weeks. When she woke up she was blind.

“It sounds like a miracle drug,” Carissa remembers thinking after seeing the Yaz commercial. You might ask yourself how a medical professional like this got fooled. Nurses take courses in pharmacology and most are not like Joe Average who just wants his problem solved and asks his doc for the latest, greatest pill. Carissa undoubtedly knew that blood clot risks are associated with all oral contraceptives. The trouble is that Bayer went out and marketed this drug even though they knew the chances it would cause an embolism were higher than those other pills – 6.3 times higher, or in different terms, 630% higher. In 2009 a Dutch study published in the British Medical Journal (BMJ) said that the type of progestin used in Yaz, drospirenone, was associated with more blood clots than other forms of the hormone. Other research has shown that low-estrogen oral contraceptives made with a type of progestin called levonorgestrel carry the lowest risk of blood clots. There were already dozens of alternatives to Yaz on the market. Bayer didn’t need to create a new contraceptive at all so they made a pill and attributed great abilities to it – all to get a patent and profits. Lots and lots of profits. Three other studies besides the one in the BMJ showed similar kinds of increased risk with Yaz. That didn’t stop the FDA from saying Bayer could sell it anyway. Hundreds have now died or been incapacitated by strokes, embolisms and heart attacks after taking the drug. Yet the pharmaceutical industry in this country is such a force that the FDA is still holding meetings to decide whether or not to do anything about it. Yaz is still on the market and is America’s number one best selling contraceptive.

The real tragedy is that Bayer knew all this. There is new information coming out every day about how bad this product is. Bayer’s conduct is so rotten that in 2008 it was fined $97.5 million by the government for running a kick-back scheme with Liberty Medical Supply, promising to pay bonuses for every patient converted to Bayer diabetic supplies. The company then had to enter into a Corporate Integrity Agreement with the Department of Health and Human Services. This agreement says Bayer can’t be trusted; it has pled to felonies and incurred incredible fines – up to $250 million. That’s what we do in America when a corporation causes harm because we can’t go the company and arrest someone. Corporations may legally be people, my friends, but they can’t be thrown in jail. As a result, when a company like Bayer wants to market a new drug they know is dangerous, they just run the numbers. They say, “Look, all we have to do is get the drug to market. Once we get FDA approval it’s going to be five or six years, no matter what kind of complaints come in. We’re going to get five or six years of sales out of this product.” At a rate of $1.8 billion in sales every year, even a $250 million dollar fine is chicken feed.

In the face of this story and dozens like it, whether from the pharmaceutical, coal, automobile or food industries, big business is constantly lobbying Congress for fewer regulations – and succeeding. We have a good ‘ol boy system, where if you go to work for the FDA, chances are you’ll go to work for Bayer. Or Pfizer. Or Abbott, Roche or GlaxoSmithKline. The people who have allowed this to happen are still allowing it to happen, even after all the body counts are in. The FDA simply says, “Well, we’re going to put a committee together who will decide how long this is going to go on.” That’s because companies like Bayer can make phone calls. Mike Papantonio, author and prominent tort litigator, refers to the phone calls as “Billy Bob calls”.  “That’s where they call Billy Bob who works for the FDA,” says Papantonio, “and says you know – I don’t think these facts are right. I don’t think these statistics are right. I think this study is bad. Could you let us keep this product on the market? And by the way, Billy Bob, we may have a position for you when you leave the FDA.” Uh-huh. And Billy Bob’s $68,000 salary working for the government becomes a cool quarter million in the private sector.

No matter how egregious corporate behavior has become in America, there is still a lot of effort on the part of politicians to slash regulations and limit awards paid out in lawsuits. The law firm that defends Bayer will make millions but lawmakers would have their client say to the person who is killed or maimed that $150,000 or $200,000 in damages in enough. Not only are the politicians pushing it – many voters are buying it.

Well hey, you can’t blame them. Life is just great when there’s no one looking over your shoulder. That is, if you’re a sociopath.

The FDA: Friendly Neighborhood Watchdog? Or Big Pharma Lapdog?

The other day a friend of mine, a nurse, by the way – touted the benefits of a weight loss remedy that has helped her to lose 31 pounds. Confident in her results, the only drawback she saw is that the drug was manufactured in China. Faces around the table fell. Manufactured in China: melamine poisoning and lead contamination. No, thanks. “But when you think about it,” I commented, “you don’t have to go to China to get tainted drugs. We have plenty of unsafe drugs right here in the good, ‘ol U.S. of A.” Turn on the tube and you see some drug maker pushing a new pill; turn the channel and there’s a lawyer suing over its adverse effects. It’s the job of the FDA to ensure that drugs released to the market are both safe and effective. But when it comes to the approval of pharmaceuticals, half of the medical evidence concerning them is hidden – the evidence that the drugs don’t work. Drugs just aren’t policed as they should be because the FDA and U.S. drug companies make very cozy albeit very strange bedfellows. Never mind the “U.S. Food and Drug Administration,” a more accurate description of the FDA might be “Federal Drug Aid”.

No government agency can operate effectively when there is a revolving door between it and the industry it is supposed to regulate. But in America the door of separation between the FDA and Big Pharma is turning 24 hours a day. A survey released by the Consumer Reports National Research Center in 2007 showed that 84% of us think that drug companies have “too much influence over the government officials who regulate them.” Over two-thirds of us are concerned over the fact that drug companies actually pay the FDA to review and approve their drugs. (Americans know their stuff, it turns out. When drug studies are funded by drug companies, positive outcomes are found at a rate of 4 to 1 over independent studies.)

92% of those surveyed agree that pharmaceutical companies should disclose the results of ALL clinical trials, not just the positive ones they want to advertise. Drug companies have buried negative drug trials and the FDA has been caught conspiring with drug companies to conceal negative drug data from the public. (To combat this, the scientific journals banded together in 2004 and refused to publish data from any drug study that didn’t publish results from all trials, positive and negative, on a central database. But listing obscure, unpublished trials in a hard-to-navigate database run by the National Institute of Health is hardly useful public disclosure.)

60% of survey respondents agreed that doctors and scientists with a financial conflict of interest should not be allowed to serve on FDA advisory boards. Doctors who earn thousands of dollars in “consulting fees” from drug companies are not only allowed to vote on recommendations for FDA approval of their drugs, there is not even any FDA requirement to disclose such conflicts of interest. (To further muddy the waters, salesmen or researchers funded by Pharma present findings at conferences funded by Pharma using presentations prepared by Pharma….!)

To put the survey results into perspective, consider cholesterol. Because a cause and effect relationship between high cholesterol and heart disease is pretty much the prevailing wisdom in medical circles, the drug industry makes a whopping 40 billion dollars a year in sales of cholesterol-lowering medications. But here’s an interesting twist: the cholesterol-lowering med, Zetia, speeds progression of heart disease DESPITE lowering cholesterol when combined with Zocor, a statin drug. This startling finding sets the drug business on its head, according to physician and four-time NY Times best-selling author, Dr. Mark Hyman, because the question of whether or not cholesterol causes heart disease was supposed to be settled. Physicians have come to believe that high cholesterol causes heart disease because the studies pushed forward by the drug industry tell them so. Statin drugs block the formation of bad cholesterol, or LDL, in the liver, but it turns out that statins actually lower risk because of a side effect not known about until after the drugs were released – they also lower inflammation. Harvard physician Paul Ritger found that heart attack risk is lowered only if c-reactive protein levels in the blood are lowered along with LDL, not just by lowering LDL levels alone. C-reactive protein levels rise in response to inflammation. Zetia was meant to be paired with cholesterol-lowering drugs like Zocor or Lipitor in order to lower cholesterol even more. The FDA released Zetia without any proof that it prevented heart attacks or reduced the progression of heart disease, but only with the idea that it lowered cholesterol and that lowering cholesterol was a good thing. It was given to 5 million people and made the drug companies about 5 billion dollars a year. That’s almost 14 million dollars a day, so when Zetia was released the drug companies had no incentive to conduct studies to prove it does what they say it does – reduce the risk of heart attack. Only after two years of foot-dragging and pressure from news agencies and Congress were the studies done and the negative data released. The FDA had the data. The question is why didn’t they speak up? Once the bad news hit the media the American Heart Association said the study about Vytorin, a combination of Zetia and Zocor, was too limited to draw a conclusion about its ability to prevent heart attacks when compared to Zocor alone. They released a recommendation that patients not stop taking Vytorin without consulting their doctors. But what they didn’t say was that they had received 2 million dollars in funding from Shearing-Plough & Merck, makers of Vytorin. The study showed that Zetia did not lower the risk of heart attack and increased fatty plaques in the arteries despite lowering cholesterol. Let that sink in for a moment. Lowering cholesterol led to more heart disease and turns our whole medical model upside down. High cholesterol, in other words, is not a disease.

What we have in America is a research mess that is flawed in 3 ways: 1. What gets studied depends on who’s paying for it, so drug companies don’t pay to study therapies that might work better, like diet and exercise. 2. Drug companies, aided by the FDA, suppress, hide or do not publish negative studies, only positive ones. This leads physicians to believe that the studies provide actual evidence instead of corporate propaganda. 3. Doctors and patients believe they have the truth even when it’s too late. The data is there but no one publicizes it.

What to do when it seems like you just can’t fight City Hall? Follow the money. Be suspicious of any study funded by drug companies. Call your representatives in Congress and demand better legislation regarding easy navigation of a database of all drug trials with user-friendly summaries of published and unpublished data submitted to the FDA. Everyone should be able to look up any drug to get balanced opinions regarding it. Finally, don’t assume that a prescription drug is the answer to your health problem. Many illnesses are the result of your lifestyle interacting with your genes.  Learn to ask, “Why?” and search for the answers. Lifestyle choices can do much to help us prevent or cope with illness. Ask your doctor to try everything else first. Then insist that the drug companies put prescription drugs where they belong – in the back-up position.