Saturday, February 7, 2009

Obesity to Yield Blockbuster Profits

"One drug expert calls the market the "biggest untapped goldmine in the industry" and speculates that it would be worth $10 billion per year."

Last October 2008, during the throes of the meltdown of the financial markets, I began subscribing to an online publication called MoneyMorning. I did so not because I own or purchase stocks, but rather, because the authors displayed a keen sense about the economy and market trends, as confirmed by other articles I read elsewhere. My romance ended today when I received advertising in my email inbox, which mailing included the following:

“On March 30th, there'll be an announcement of FDA results for a new drug that could create the single biggest return of any investment we've ever found, in 10 years.”

“Quite simply, we expect approval for a new drug unlike anything to ever go public in the 81-year history of modern biotech. It's a drug that simply hasn't existed, in any useable form ... until the company I'm telling you about invented it.”

“So far - the drug has successfully cleared both Phase 1 and 2 FDA clinical trials and and is just weeks from the announcement of Phase 3 results... the last trial before it could launch on a scale potentially unseen since the release of penicillin.”

“In short: as of Dec. 15, 2008, early clinical results suggest the drug is safe...has a near-perfect success rate... has a 500% efficiency... and finally, get this: will target 45% of the U.S. population - almost 1 out of 2 Americans.”

“In other words: if the results are positive for this new drug on March 30th as we expect ... a single stake in this company could make you a fortune, overnight. We estimate as much as $195,600... but only if you get in right now…”

“Big Pharma is pouring tens of millions into the effort. Many speculate a drug that successfully treats this problem … would be, "the last of the traditional blockbusters...drugs that weigh in over $1 billion annually."

“One drug expert calls the market the "biggest untapped goldmine in the industry" and speculates that it would be worth $10 billion per year. That's why shares of the little drug developer I've been telling you about could go through the roof on March 30th, on the announcement of Phase 3 test results.”

“With just a single lowers the patient's weight by at least 5% (the golden mean in weight loss). If a patient can lose 5% of fat - academic studies have shown that this significantly lowers blood pressure...risk of heart disease, and other harmful effects like diabetes... arthritis...and stroke.”

“Even more amazing - unlike almost every other weight-loss alternative, the drug works without a single ounce of effort from the patient... In other words: It requires no exercise ... no special diet ... and no risky operations in the hospital. You simply swallow the pill on a full or an empty stomach.”

Stunned and disgusted, I unsubscribed immediately. And here's why: The missive in my mailbox constitutes false and misleading advertising for a nummber of reasons. As a threshold matter, the advertised company is not the only one in a race to corner the obesity market: Neurosearch, a Scandinavian company, is well ahead with the development of Tesofensine, and published its phase III trial results in November 2008.

Second, the advertised company itself asserts that it is scheduled to release major Phase III trial results in September and thereafter file an application for the drug's approval by “late 2009.” Thus the rouse about March 30th is an effort to rope investors prior to release of Phase III trial results.

Moreover, the admen blatantly belie the FDA's statutory requirements for the approval of new drugs. Which means that there is no guarantee of FDA approval on March 30th. If the FDA does issue a statement on that day, such statement will pertain to the results of the Phase III clinical trials, not actual FDA approval, which usually takes at least six months. This misleading advertising also failed to disclose that companies are not limited to one Phase 3 trial; companies are often required to submit additional research regarding safety and efficacy, depending on the clinical results, third party comments and or the FDA’s response.

The obesity drug to be peddled to unwitting patients is Lorcaserin, and the penny stock company developer is Arena Pharmaceuticals (nasdaq: ARNA). Read a more detailed discussion here in an October 2007 Forbes article titled “The Next Fat Pill”. According to that piece, “[t]he closest thing to a real success weight-loss pill that's safe and reliable … was fen-phen, helped people lose as much as 30 pounds a year … but was pulled off the market in 1997 [because] it caused heart valve problems … and pulmonary hypertension…” Reportedly, the recall occured after Fen-phen maker Wyeth (now owned by Pfizer) paid $18.7 billion to settle the lawsuits.

Furthermore, according to Forbes, “Lorcaserin stimulates production of serotonin, the same brain chemical that fen-phen did. But Arena executives and obesity experts say it has none of the heart valve risks because it is targeted to the brain.” In fact, in June 2007 the FDA denied approval of Paris-based Sanofi-Aventis (nyse: SNY) brain targeted obesity drug, Acomplia, because of side effects that included suicidal thoughts and depression. SNY eventually withdrew Acomplia from the market.

Big Pharma apparently intends to prey on the American propensity for a quick fix and the expectation of a magic pill that will permit users to deny responsibility for their own health. Read a Wikipedia article specifically suggesting that Lorcaserin weight loss is succesfull only if one continues to take the the drug. All of which means continuous and indefinate purchases by the addicted obese - and in all likelihood, fabulous profits to Big Pharma manufacturers and distribution chains.

Sunday, February 1, 2009

U.S. Proper Forum for Trovan Lawsuit

The U.S. Court of Appeals for the 2nd Circuit in New York ruled on January 31st that Nigerian lawsuits against Pfizer can now go forward in the U.S. courts. Previously, the District Court had dismissed the case on the grounds that it could not be pursued under the 1789 Alien Tort Claims Act, a statute that permits foreigners to sue in the US courts.

The Nigeria plaintiff's case has been flailing around for some time - since 1996 - and there are a lot of related claims, including violation of Nigerian and International Law, and possible fraudulent alliances. Read more about the tangled genesis of this case here and here.

In essence, it is alleged that during a meningitis epidemic, Pfizer tested the oral antibiotic, Trovan, on some 200 ill children in a hospital in Kano, without first getting the consent of their parents. Trovan was initially approved by the FDA for an unprecedented fourteen indications.

Pfizer has since denied the charges and settlement talks are at a stalemate. Even then, hugh questions remain. According to the testimony of Dr. Sidney M. Wolfe before the House Health Subcommittee in 2005, "there was clear evidence of liver damage caused by Trovan (in animals and in humans) before the drug was approved in December 1997."

Yet on June 9, 1999, at the time that the FDA issued its public health advisory to physicians concerning the risks of liver toxicity associated with the use of Trovan, the FDA permitted the continued sale of Trovan, “limit[ing]” its use in the United States to patients who were either hospitalized or in nursing homes! Shockingly, the demonstrated issues with the drug’s safety, efficacy and quality did not apply to the most vulnerable class of certain U.S. recipients.

Sale of Trovan waned in Europe following the FDA boxed warning , but then it required more and more cases of liver failure and death to occur before Pfizer quietly discontinued making the drug in 2002. Even so, during the latest year for which U.S. sales data are available (March 2004 through February 2005), there were still 18,000 prescriptions for Trovan filled in the U.S - long after Pfizer had reportedly stopped manufacturing the drug.

This author suggests that the 2nd Circuit opinion is sound in all respects: Pfizer should not be permitted to use the US judicial system to effectively deny access to foreigners injured or killed by its lethal drugs.

Tuesday, May 22, 2007

Marketing Lethal Drugs

"Misbranding of OxyContin leads to $600 million in fines". New York Times

The pharmaceutical industry claim that they provide valuable services to physicians has lately been subject of harsh spotlight. Today we learn that Purdue Frederick, a division of Purdue Pharma, and three of its top executives, pleaded guilty to the criminal violation of misbranding and will pay a total of $34.5 million in fines.

The drug is OxyContin, a powerful narcotic that provides long-lasting [up to 12 hours] relief for serious pain. It is alleged Purdue Pharma misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused. The Company did so by asserting in marketing materials that OxyContin, because of its time-release formulation, posed a lower threat of abuse and addiction to patients than do traditional, shorter-acting painkillers like Percocet or Vicodin. These non-FDA approved, false marketing claims were dropped only in 2001, amid heavy regulatory scrutiny. To add insult to injury, Purdue Pharma reportedly marketed OxyContin mostly to general practitioners (prescriber profile purchased from the AMA), who had often had little training in the treatment of serious pain or in recognizing signs of drug abuse in patients.

"Misbranding" is a broad statute that makes it a crime to mislabel a drug, fraudulently promote it or market it for an unapproved use. Stepped-up enforcement under this statute should help curb some of the abuses in pharmaceutical marketing practices. The fines in this case are insufficient, in light of the massive profits Pharma-Purdue earned from the illegal activity. This is also a clear case of white-colar "drug dealers" getting off with a pat on the hand.

Doctors Reject Prescriber Profiling

"We don't like the practice, and we want it to stop..." Jean Silver-Isenstadt

The quote is by the Executive Director of the National Physicians Alliance, NPA, a group whose members are mostly young doctors in training. Ms. Silver-Isenstadt was commenting on a Kennebec Journal article asserting that pharmaceutical company data-mining of a doctors prescriptive history serves mainly to influence physicians to prescribe more expensive medicines, instead of to provide the best treatment. She also said: "We think it's a contaminant to the doctor-patient relationship, and it's driving up costs."

We would like to support the physicians at NPA for taking this step to stand up to the powerful pharmaceutical lobby. Pharmaceutical marketing to physicians is a significant issue of national concern. The May 15th edition of the Annals of Internal Medicine includes an in-depth editorial titled "Prescriber Profiling: Time to Call It Quits". The author, a doctor, concludes that if physicians want prescriber profiling to end, they must lobby state legislatures to enact laws, lobby their professional organization to support such laws, and call on the AMA to place further limits on selling physician data for use in prescriber profiling. Physicians should also refuse to participate in marketing research that generates prescribing patterns because the primary purpose of this practice is to enhance sales, not patient welfare.

If NPA is serious about its mission, the time has come for physicians to roll back the influence of commercial marketing practices on clinical decisions. John and Jane Public can now rest assured that the doctors of the future are aware of the conflicts arising from drug company solicitations and that those doctors are willing to place the interest of the patient first, before profits.

Tuesday, May 15, 2007

Anti-anemia Drugs Reach Blockbuster Status

"The explosion in the use of three anti-anemia drugs to treat cancer and kidney patients illustrates much that is wrong in the American pharmaceutical marketplace. The New York Times

On april 27th, we reported about drug company payments to physicians and how certain pharmaceutical companies were making a killing of the sale of anti-anemia drugs. At the time we noted the massive profits were due to the fact that doctors usually buy the drugs from the pharmaceutical companies, that they get reimbursed for much of the cost by Medicare and private insurers, and on top of that they receive rebates based on the amount they have purchased. Today we have a New York Times editorial weighing in on these issues:

Anti-anemia drug dosage levels may be harmful to patients; financial incentives have led to wider use and the prescribing of higher doses than medically desirable; lax regulators permit reckless promotional ads; dialysis patients are injected with drug dosages that raise their red blood cell counts to levels deemed risky by the Food and Drug Administration; and studies show that anti-anemia drugs make some cancers worse or hasten the deaths of cancer chemotherapy patients.

The only way to stem the the overprescription of anti-anemia drugs is to remove the financial incentives. Federal laws already bar drug companies from paying doctors to prescribe medicines in pill form. That prohibition should be extended to injected and intravenous medicines. The Federal Anti-Kickback Statute is also a useful tool that could be put to good use in this regard.

Wednesday, May 9, 2007

Cheap Prescription Drugs Denied Access

"The Senate Guts Drug Bill." Trouthout

As usual, might won over right. Last time I posted here about proposed amendments to the PDUFA. Well, true to form, the United States Senate voted to not allow the importation of cheaper prescription drugs from Canada and other countries. The stated basis of this voting was that the Food and Drug Administration cannot certify the imports would be safe and effective.

This vote is justified to the extent that the FDA does not have and cannot afford the resources to create the bureaucracy that would be required by a certification procedure. However, this defense is a strawman specifically erected so that it could be knocked down. If imports were accepted, there would be no need to certify them as safe since those drugs would have already been approved by the FDA. One sponsor of the bill went as far as to assert: "arguments that imports would open the door to dangerous counterfeits are nonsense perpetrated by big drug companies protecting their profits."

I agree. There is also the millions in user fees the FDA collects for reviewing applications from pharmaceutical companies. Permitting the re-importation of cheap, American prescription drugs is not the purpose of the current review of the Prescription Drug User fee Act, scheduled to expire in September. Rather, the sole purpose is to provide for continuation and substantially increase of the user fees paid to the FDA. Thus we see that the cheap drug re-import debate was merely a smokescreen engineered to distract from the real reasons for review of the statute.