Back in February, we ran a guest blog post here on the Prescription Access Litigation blog titled “Nat’l Women’s Health Network debunks ‘Hands Off My Estrogens!’ Ad on FDA enforcement re: “bioidential hormones”” The post addressed ads that a group called Hands Off My Estrogens ran in several major newspapers. The ads criticized the FDA for cracking down on the sales of estriol, an unapproved drug that has not been proven safe and effective. The National Women’s Health Network’s blog post analyzed the ad and its claims.

Well, we’re back for some more on the hot-button issue — last month, a group of Congressional Reps sponsored a resolution criticizing the FDA for taking action on unapproved hormones distributed by compounding pharmacies. Below is another guest blog entry by the National Women’s Health Network on this issue. We note that the National Women’s Health Network does not accept money or donations from pharmaceutical companies.

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The public’s confidence in the safety of the U.S. drug supply and in the Food and Drug Administration’s (FDA) commitment to protecting public health have been shaken by repeated drug safety scandals in recent years. So when your health care providers say one thing and the FDA says another, whom do you trust?

It’s not always an easy question to answer, but one thing is clear: drug safety decisions shouldn’t be made by politicians. We need legislators who will make sure the FDA has the authority and resources to protect our health. Unfortunately, last month members of Congress jumped into the fray in a less than helpful way, challenging an FDA decision that had stirred up controversy about the safety and effectiveness of “bioidentical” – or natural – hormones that compounding pharmacies had been selling to women as an alternative to conventional hormone replacement therapy.

Earlier this year, the Food and Drug Administration took a firm and public stand against the false and misleading promotion of natural hormones and outlined several marketing claims that it had found to be unsupported by medical evidence. The agency specifically warned that selling estriol, a chemical that has never been approved by the FDA, is a violation of federal law. (See PAL’s blog entry from dateTK, to read more about the FDA decision.)

It is this last action – the effort to stop sales of estriol – that prompted Congressional action. House Concurrent Resolution 342 calls on the FDA to reverse its policy on compounded medications containing estriol. Representative Gabrielle Giffords of Arizona, one of the original cosponsors of the resolution, says that allowing the FDA’s action on estriol to stand “would unnecessarily disrupt the lives of countless women.” She says doctors should decide which medications are safe for their patients, and the FDA shouldn’t “inject itself into the doctor-patient relationship.”

In a world turned upside down, consumer advocates who have been responsible for helping to bring to light many of the drug safety scandals that have shaken public confidence in the FDA have come to the agency’s defense. The National Women’s Health Network (NWHN), the Center for Medical Consumers, the Government Accountability Project, the National Consumers League, and the National Research Center for Women & Families wrote to Congress, to express our strong opposition to the resolution. We pointed out that estriol has not been clinically proven safe and effective and has not been approved by the FDA for any use. We also noted that compounding pharmacies selling estriol are telling women that estriol is safer and more effective than other hormone therapy products and that it will prevent serious diseases, despite a lack of scientific evidence to support these claims.

With doctors and pharmacists telling them one thing and the FDA telling them another, where can women go to get the facts? On the NWHN website, we have fact sheets for women with reliable, science-based information about conventional hormone therapy and alternatives, including natural hormones. Research on conventional hormone therapy has shown that it can increase a woman’s risk for heart disease, breast cancer and stroke. Research on natural hormones is spotty, and most of these drugs haven’t been adequately tested to support the claims being made and safety or effectiveness. When it comes to estriol, studies have found mixed results about whether it hurts or helps with breast cancer, but it’s clear that it increases the risk for endometrial cancer. Yet few of the women taking estriol have been provided with that warning.

But it’s not enough to give women information on a case by case basis. We need an FDA that we can count on to make sure that the drugs being marketed to women are safe and effective. And we need a Congress that understands and supports the important role of the FDA in regulating the drug industry. Preventing the sale of an unapproved drug is one of the most basic functions of the FDA; and yet with the estriol resolution in the House of Representatives, we have legislators claiming that it’s inappropriate for the agency to come between patients and doctors to do just that.

It’s unfortunate that the FDA’s failure to act on drug safety problems in so many cases has left women uncertain about whom to trust on questions about the safety and effectiveness of natural hormones. The case of estriol is a powerful example of why we need to build up the FDA’s capacity to evaluate and monitor drug safety, and reinvigorate the scientific leadership and integrity of the agency.

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Thanks to National Women’s Health Network for contributing this guest blog post… Readers, we welcome your comments!

Dean Baker, from the Center for Economic and Policy Research, has a great piece up on truthout.org called Firefighters and Prescription Drugs. Baker has frequently written in the past on the perversity of our current patent-based system for developing new drugs, and what alternatives there are. (See, for example, Financing Drug Research: What Are the Issues?)

Baker’s main point is that we have accepted the current system of using the incentive of a patent to spur research and development as inevitable and natural. It brings to mind the saying “the fish are the last ones to notice the water.” It’s vital to remember that there’s nothing natural or inherent about that system, however.

This is the system that has brought us more than 8 prescription drugs for heartburn, and more than 4 for erectile dysfunction, but no meaningful new treatments for diseases that are true scourges of humanity, like malaria and tuberculosis. Other systems might work much better at creating incentives to develop treatments, particularly for these neglected diseases that affect millions of people who happen to have the rotten luck to live in poor countries rather than in the U.S. where TV ads work to convince us all that we have restless leg syndrome, insomnia, and toenail fungus.

It’s telling that although all of the presidential candidates have talked about the greed of pharmaceutical companies, none have even dared to mention, let alone question, the conventional wisdom about how we develop drugs.

Baker offers a variety of proposals, such as increasing the budget for the National Institutes of Health, running all clinical trials through the NIH, etc. Publicly-funded medical research has a vital role to play — and we need to make sure that we don’t pay twice for drugs and medical treatments that are developed with public funds — once when we pay for the research, and again when we are forced to pay exorbitant prices for the drugs that result from that research. The discovery of Abbott Laboratories’ [NYSE:ABT] HIV/AIDS drug Norvir was made possible by an NIH research grant, yet that didn’t stop Abbott from quintupling the price of the drug. [PAL member SEIU Health & Welfare Fund is a plaintiff in an ongoing class action lawsuit against Abbott for this price increase. See more about that case here.)

Some highlights of the truthout.org piece:

The most remarkable part of this story is we do not even have a public debate on how we finance drug research. The United States is currently spending almost $250 billion a year for prescription drugs. If drugs were sold in a competitive market, without government-imposed patent monopolies, we could save close to $200 billion a year. The $200 billion in higher drug prices buys a bit less than $25 billion a year in pharmaceutical research, according to the Congressional Budget Office. Paying $8 in higher drug prices for $1 in research does not seem like a very good deal.

Furthermore, as economists who don’t work for the drug companies will tell you, the huge markups created by patent monopolies are an invitation to corruption. When a drug company can sell a drug for $500 that costs it $4 to manufacture and distribute, it has an enormous incentive to mislead doctors and the public about the safety and effectiveness of the drug. And, when the drug company performs the research on the drug, and controls the dissemination of research findings, they also have the ability to act on this incentive.

Under the current system, we should not be surprised to find drug companies conceal evidence that their drugs might be ineffective or even harmful. Given the structure of the incentives that the government has created, we should be surprised if drug companies are not dishonest.

There are many different alternatives to patent monopolies for financing drug research. In fact, the US government already spends $30 billion a year on biomedical research through the National Institutes of Health. Virtually everyone, including the drug companies, agrees this government-funded research has been extremely valuable…

We should be having a serious national debate on the relative efficiency of the current patent system and various alternative mechanisms for financing drug research. Unfortunately, the drug companies are so powerful that few politicians are even willing to consider alternatives. In fact, the drug companies are so powerful that few media outlets would even print a column suggesting alternatives. In fact, the drug companies are so powerful that few economists would ever consider researching alternative mechanisms.

To read the full piece, go here

Hat Tip: Suddenly Senior