Pharma biggie GlaxoSmithKline has already been slapped upside the head with a $3 billion settlement with the federal government regarding the marketing of, among others, the once-popular diabetes drug Avandia. Today, the attorneys general of 37 states rubbed a bit of salt in the wound with a $90 million settlement of their own. [More]
Colchicine, a drug primarily used to treat gout, is an old drug. Very old. Extracts from the plant it comes from, colchicum, have been used in gout treatment for thousands of years. In pill form as colchicine, it’s been on the market in the United States since the 19th century and predates the Food and Drug Administration. A few years ago, the company that makes one brand of the drug, Colcrys, obtained FDA approval for their version, and the exclusive rights to sell it in the United States for three years. Who cares? Reader Nick does. He works in retail, isn’t wealthy, and the colchicine he takes twice a day for a serious medical condition shot up in cost from about $20 per month to closer to $400. [More]
Researchers at the University of British Columbia in Vancouver looked at sales figures and prices for the blood thinner Plavix after direct-to-consumer advertising started in 2001. What they found was that the campaign was largely ineffective at increasing prescribing rates, but that the price of the drug shot up 12% almost immediately to cover the cost of the marketing campaign. [More]
Vermont Gets Tough On Doctor/Pharma Relationships The new law “bans drug companies-and manufacturers of medical devices and biological products, such as vaccines-from paying for gifts, including meals and travel, to physicians, hospitals, nursing homes, pharmacists, and health plan administrators. Any allowable payments drug companies make to doctors, such as those for legitimate educational purposes, will be posted in a database on a public website maintained by the Vermont Attorney General.” [Consumer Reports Health]
Who knew botulism could be so awesome? Botox is Allergan’s cash cow, earning the pharmaceutical company $1.3 billion last year alone. The funny thing about the toxin—originally developed as a biological weapon—is it works for a lot of “off-label” uses as well (like treating anal fissures and preventing hair loss), and Allergan says that non-cosmetic applications could be an even bigger market because health insurers will help pay for the treatments. Likely upcoming FDA-approved treatments: stroke-induced muscle spasms, chronic migraines, and enlarged prostates.
The Supreme Court ruled 6-3 in favor of Diana Levine in Wyeth v. Levine. Levine, a musician, had her arm amputated when an anti-nausea drug was improperly administered in her artery, and sued the manufacturer for failing to warn of the risks on the drug’s label. Wyeth claimed that her case was pre-empted by federal law.
Psychiatry is nothing more than a well-funded front for big pharma, according to lawmakers investigating the field’s premier organization, the American Psychiatric Association. Unlike psychologists, psychiatrists can write prescriptions, giving pharmaceutical companies a powerful incentive to lavishly subsidize both their lifestyle and profession.
GlaxoSmithKline is buying a U.S. biotechnology company that is researching resveratrol, the chemical compound found in red wine that may retard the aging process. The CEO of the company says that “drugs that mimic resveratrol, by activating enzymes called sirtuins, could ‘treat in a safe, natural new way, many of the major killers of western society.’” We can’t wait to see the commercials that GSK puts out for this one.
Pre-Emption Doctrine Would Make FDA Responsible For All Drug Problems, Shield Big Pharma From Lawsuits
Johnson & Johnson is waiting to hear whether or not a judge in Ohio will allow any lawsuits over its Ortho birth control patch to move forward, and the New York Times says lawyers on both sides think there’s a good chance he may find in the company’s favor based on the doctrine of pre-emption. The argument goes that it’s the FDA’s responsibility to monitor the safety and labeling of drugs that go to market, and therefore if something goes wrong, it’s the agency’s fault and not the pharmaceutical company’s.
The Prescription Access Litigation (PAL) coalition filed suit against 11 drug companies in 2002 for artificially inflating the average wholesale price, or AWP, of certain drugs, including ones used to treat serious illnesses such as cancer and HIV. This week, PAL announced that the companies have agreed to pay $125 million to settle—82.5% of the amount will be used to compensate third-party payor’s claims, and the remaining 17.5% will be used for consumer claims. Here’s a list of the drugs involved, and after the jump is a quick guide to see whether you’ll qualify for a claim, pending the judge’s approval of the settlement.
Two former sales reps for the pharmaceutical company Amgen are suing “for lost wages and other compensation after refusing to participate in improper promotion of the company’s blockbuster psoriasis drug Enbrel.” They claim that Amgen encouraged them to “illegally access patient records to induce insurance carriers to pay for the pricey drug,” according to their attorney. Amgen promptly responded that the suits were without merit, and then handed out blister packets of popular drugs, branded desk calendars, and free t-shirts, so everything’s cool.
Dr. Robert Jarvik is the inventor of the Jarvik artificial heart, right? You know that because he’s the pitch-man for Lipitor, a heavily advertised cholesterol drug. Have you ever stopped to ask yourself why inventing an artificial heart qualifies the man to pitch a drug?
Pfizer is in panic mode about its rapid decline in Lipitor sales—in the last 18 months, it has dropped from 40% of the market for cholesterol-lowering drugs to 30%, and likely to drop further—so it’s launched a big media-blitz to convince people not to switch to simvastatin, the generic version of its name-brand competitor, Zocor. Zocor was more expensive than Lipitor, so Pfizer had nothing to worry about for years—but then Zocor lost its patent protection last year, and now doctors are switching patients from Lipitor over to Zocor’s generic twin to save money.
Zyprexa, Lilly’s best-selling drug to treat schizophrenia, has been shown to cause “cause weight gain, high blood sugar, high cholesterol and other metabolic problems,” but until now, the company has refused to add any warnings about these side effects to the label. Now, sparked in part by lower sales, Lilly has announced that Zyprexa will warn consumers that it can cause high blood sugar. The American Diabetes Association claims that Zyprexa causes diabetes, but this isn’t addressed on the new warning labels.
Starting today at 10 a.m., the powerful Chairman of the House Energy and Commerce Committee, John Dingell (D-MI), will hold a hearing on H.R. 3610, The Food and Drug Import Safety Act of 2007, or, as we have dubbed the bill, The Poison-Free Food Act. The bill would dramatically alter the FDA’s handling of imported foods, empowering the agency to:
- Issue mandatory recalls;
- Limit food imports to ports clustered near FDA inspection labs;
- Require a country of origin labels for food, drugs and medical devices;
- Subject exporters to a strict certification program administered by the Department of Health and Human Services.
The Committee will hear from two panels: The first will see FDA Commissioners and regulators defending their agency, while the second will host a panoply of foodies, including the Coalition for a Stronger FDA, the Center for Science in the Public Interest, the Grocery Manufacturers Association, and Big Pharma.
Since the study was published, Consumer Reports has come out in favor of older drugs:
Diabetes drugs received wide attention last spring when research found a possible link between rosiglitazone (Avandia) and a higher risk of heart attacks. While those risks remain unclear, the CR Best Buy Drug report cites other reasons that rosiglitazone and the related drug pioglitazone (Actos) are not wise first choices for most people with diabetes, including their higher risk of heart failure compared with other diabetes drugs.
Consumer Reports that patients should first ask their doctors about metformin (Glucophage and generic), claiming that the effectiveness of the older drugs are equivalent to the newer ones, but with less potential risk.