Yes. Last week, the four most recent commissioners of the U.S. Food and Drug Administration sent an open letter to Congress declaring that an importation bill, The Affordable and Safe Prescription Drug Importation Act, introduced by Senators Bernie Sanders, Cory Booker, and Bob Casey, if passed, would jeopardize consumer safety. The bill, as described here, provides for an extensive oversight role for the FDA to help individuals and pharmacies import lower cost medications from Canada.
Don’t get me wrong: the former FDA leaders make pertinent points about regulatory issues implicated in reforming our importation laws, which should be noted – and then used to implement new regulations to expand importation from Canada – not used to pretend safe importation is impossible.
Thankfully, when the Washington Post covered this last week, they included something I said to the reporter: “The Internet has been a lifeline of affordable medicines, imported for personal use by using safe international online pharmacies that require valid prescriptions…” And if I had more to say… (more…)
Tagged with: FDA, letter to congress, Roger Bate, sanders
It’s time to get real
In 2005, as reported here, an executive from the Pharmaceutical Researchers and Manufacturers of America (PhRMA or Big Pharma), agreed to commission, to the tune of $300,000, the writing of a fictional novel in which Muslim terrorists poison prescription drugs in Canada to kill Americans who – seeking affordable medication – buy drugs from Canada. The deal with the publisher didn’t work out. As the authors tell it, PhRMA offered money to shut them up but they said no. They instead wrote a book about a pharmaceutical company who poisoned Canadian drugs and made it look like Muslim terrorists did it. Nope, I couldn’t make this up. That book – The Karasik Conspiracy – is available on Amazon.
Fake news is in the news a lot lately! Like fake news, efforts to dissuade Americans from obtaining safe lower cost medication through personal drug importation can have dangerous consequences: people scared away from safe medication they can afford. There are – in fact – very safe international online pharmacies and dangerous rogue pharmacy sites. Stick to the former avoid the latter. There are tens of millions of Americans not taking medications because of cost — so it’s time to get real. (more…)
Tagged with: AEI, fake news, medscape, Roger Bate, webmd, who
As we all know, an unaffordable drug is neither safe nor effective. No less true, an ineffective drug, whether dirt cheap or super expensive, can have hazardous health consequences, even death. That’s why consumers seeking low cost medication online look to avoid bad meds by finding accredited online pharmacies with a PharmacyChecker or VIPPS seal. But that might not always be good enough…
People don’t like to talk about it but sometimes switching from a brand name med to an “equivalent” generic can lead to serious health problems. And this happens at your local U.S. pharmacy, not just online. Tod Cooperman, MD, president of PharmacyChecker.com, knows about this more than most people. In his capacity as president of ConsumerLab.com, he participated on an expert panel at a Congressional briefing this past Wednesday, organized by a new group called the Safe Medicines Coalition led by economist and counterfeit drug expert Roger Bate, PhD. The panelists and others are authors of a new paper called “Drug Inequality: Allowable Variations and Illegal Underperformance in Off-Patent Drugs.”
Dr. Cooperman’s main contribution to the panel comes from his experience testing a generic version of the anti-depressant Wellbutrin XL. To make a long story short, in 2007 ConsumerLab.com tested Teva’s FDA approved generic of the 300 mg version called Budeprion XL – an extended-release product. A generic drug that is bioequivalent to the brand name drug is supposed to work pretty much the exact same way as the brand. Consumerlab.com found that Teva’s generic did not dissolve like Wellbutrin XL – it released the drug much too quickly. It took the FDA more than 5 years but it finally conceded that the product was not bioequivalent to the brand product because it released the active ingredient much faster.
According to the People’s Pharmacy, people taking this generic were feeling more depressed, and even suicidal – until they switched back to the brand or to a different generic. The People’s Pharmacy and ConsumerLab.com shared this information with the FDA back in 2007 only to be ignored.
In order for the FDA to approve a generic drug for sale in the U.S., it must be proven to be bioequivalent to the brand name drug –delivering approximately the same amount of drug over the same amount of time in a group of healthy volunteers. It turns out that Teva never did this for the 300 mg version of Budeprion XL. The FDA approved the drug anyway, based on the data and approval for a lower strength version, Budeprion XL 150mg. What’s more amazing is that generic medications, even though they are not the exact same as their brand name counterparts, under U.S. law, must have the exact same clinical data in their package inserts as the brand name drug. That is, the data shown in the insert is NOT actually the data for that generic. This is meant to give the impression that all generics are the same as the brand name product, even though that’s not the case. If that doesn’t seem to make sense then you’re thinking clearly.
In 2012, the FDA admitted ConsumerLab.com had been right, and stated that Budeprion XL 300mg is was not bioequivalent to Wellbutrin XL 300mg.
Dr. Harry Lever, a cardiologist, talked about patients who were not responding well when switched to certain generic heart medications, such as beta blockers. Most interestingly, problems not only occurred when patients switched from brand to generic but even from generic to generic, which takes us back to the efforts of ConsumerLab.com above and moves us into a new point: Not all generic drugs are equal to each other, and a particular generic might work better in one patient than another!
The key takeaway from Dr. Lever’s and Dr. Cooperman’s presentations is that if a certain generic drug is working for you, then try and stay on that exact same medication. You’ll find it’s not easy because pharmacies often interchange generic drugs in their dispensing practices. You can avoid this by making sure you ask for the same generic, meaning the same manufacturer, each time you visit the pharmacy.
Mr. Bate focused on the fact that drug quality, generally, is not equal from manufacturer to manufacturer, brand to generic, generic to generic, country to country, etc. Mr. Bate is not saying that most generic drugs don’t work but simply that they are not exactly the same. Dr. Preston Mason supported this by presenting data based on testing generic versions of Pfizer’s Lipitor. He found that different versions were not all equal. The lowest quality products, based on number of impurities, were made in India for export to poorer countries.
The final presenter was Dinesh Thakur, the whistleblower that outed major manufacturing problems and corruption at Indian drug manufacturer Ranbaxy. Ranbaxy was actually granted the first go at marketing generic Lipitor in the U.S., but their version was eventually recalled due to small particles of glass that may have contaminated the product. You might find FDA’s nuanced position on the recall instructive and of great interest: “Patients who have the recalled medicine can continue taking it unless directed otherwise by their physician or health care provider….To date, FDA hasn’t received any reports of injury….The possibility of adverse health problems related to the recalled atorvastatin is extremely low.” I don’t recall hearing that the drug was not effective either but its recall was precautionary.
So what the hell are average consumers and even their healthcare providers to make of all of this? I’m going to copy and paste from ConsumerLab.com:
- If a generic doesn’t work like the original drug, be concerned, particularly if it is an extended release (often called “XL”) product.
- Be aware that the labeling on a generic drug describing its performance is copied from the labeling of the original product and may not reflect the performance of the generic. This is a deception required by the FDA, perhaps to create the perception of generics as interchangeable.
- If a generic works for you, look carefully at the label and identify the manufacturer. Request the same manufacturer each time you refill that prescription. Other generics may not behave the same way.
From my perspective, despite the FDA debacle with generic Wellbutrin XL discussed above, the FDA is one of the best drug regulatory agencies in the world. Following the advice above, you can and should trust generic drugs sold in the United States. What about generic drugs sold over the Internet from foreign countries? Pharmaceuticals sold in the most highly regulated countries are generally equivalent in quality and efficacy to those sold in the United States. What about from Indian pharmacies? The highest quality medications sold in Indian pharmacies are on a par with those sold in the U.S., too, but there’s more deviation and far too little oversight from the Central Drugs Standards Controller Organization, India’s FDA.
For all of these reasons, if you’re buying online and getting a drug internationally stay away from websites that are not credentialed by PharmacyChecker.com. And remember, despite crazy price increases in a good number of generic drugs, most generic medications approved for sale in the U.S., sold at local pharmacies are less expensive than International online pharmacy prices – even cheaper than India! However, brand name products are usually far less expensive outside the U.S. (and apparently sometimes safer than generics) – and you can check those prices on www.PharmacyChecker.com.
Tagged with: Consumerlab.com, Roger Bate, Safe Medicines Coalition, Tod Cooperman, VIPPS
Dr. Roger Bate, an economist who publishes extensively about drug quality, safety, and intellectual property, finds himself a bit out in the cold right now and we think that’s wrong. It’s all because of his latest work on Internet pharmacies and personal drug importation.
He was once a favorite of the pharmaceutical industry. In a 2004 National Review article called “What Patent Problem?” Dr. Bate enraged the progressive, health activist community for arguing that patents are not obstacles to needed medication in poor countries because 95% of World Health Organization Essential Medicines are already off patent. Arguments like those were welcomed by industry, but things have changed. His recent research showing that personal drug importation (which undermines pharmaceutical profits) through online pharmacies can be safe has made him persona non grata in some pharma circles, despite his other positions which support pharma. Unfortunately, it seems the health activist community is also hesitant to embrace Dr. Bate’s current work on personal drug importation, perhaps because they don’t want to lend credence to his past research.
We think it’s time that everyone, including the FDA, listens carefully to what Dr. Bate is saying about personal drug importation. After extensive mystery shopping and testing of products, Dr. Bate came to a very simple conclusion: As long as people purchased medication from websites (foreign or domestic) approved by PharmacyChecker.com or the National Association of Boards of Pharmacy, they were generally safe doing so. His data also showed that Americans could save a lot of money (an average of 52%) on brand name medicines from legitimate pharmacies outside the U.S. He believes this option, to be fair, should exist mainly for lower income individuals rather than people able to afford U.S. prices.
Dr. Bate’s conclusions about online pharmacy are an inconvenient truth for the pharmaceutical industry and U.S. pharmacies – which include some of the funders of his employer, the American Enterprise Institute. These industries lobby the government to prevent Americans from accessing drugs online at lower cost from foreign pharmacies. Their strategy has been to ignore Dr. Bate’s findings on Internet pharmacies. The FDA seems to be playing the same game by scaring the public away from personal drug importation through public information campaigns, such as Be Safe Rx.
We know that Dr. Bate’s work on online pharmacies is guided by hard data, objective analysis, and his free market sensibilities. We do not agree with his positions on all subjects, but his studies on drug safety demand respect from all sides and could help policy-makers reach the right conclusions for the public good.
Tagged with: Counterfeit Medication, Online Pharmacies, Pharma, Roger Bate
The main Op-Ed article in today’s New York Times, “The Wrong Way to Stop Fake Drugs,” calls for the legalization of personal drug importation from credentialed international online pharmacies, such as those approved in the PharmacyChecker.com Verification Program. Authored by Roger Bate, a resident scholar at American Enterprise Institute, the central message of the piece is that the technical ban on personal drug importation does not help the fight against counterfeit drugs but does discourage Americans from getting needed medication. We couldn’t agree more.
Dr. Bate offers evidence-based and compassionate approaches to help uninsured/underinsured Americans obtain medication at affordable prices and reduce the threat of counterfeit medication domestically and abroad. For more on this story see today’s press release
For the past year, Americans who buy medication from international online pharmacies have engaged through RxRights.org to help stop government actions that could block their online access to safe and affordable medication. Taking the cue from this latest op-ed, Americans should start asking their leaders to pass legislation directing the FDA to provide accurate information about online pharmacies. At the very least, the FDA should cease its categorical warning against all international online pharmacies for the simple reason that some are very safe and can help more Americans afford needed medications.
We looked at the top five brand name drugs by sales today to highlight the incredible price discrepancies between US pharmacy and international online pharmacy prices.
Tagged with: affordable prescriptions, international pharmacies, New York Times, Online Pharmacies, prescription drug importation, prescription legislation, Roger Bate